Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00267098
First received: December 19, 2005
Last updated: February 20, 2014
Last verified: February 2014
Results First Received: December 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrioventricular Block
Heart Diseases
Intervention: Device: Cardiac Resynchronization Therapy (CRT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Implant Attempt Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
Unsuccessful Implants Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
CRT-P: Biventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
CRT-P: Right Ventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
CRT-P: Not Randomized Subjects successfully implanted with a CRT-P device who were not randomized
CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
CRT-D: Not Randomized Subjects successfully implanted with a CRT-D device who were not randomized

Participant Flow:   Overall Study
    No Implant Attempt     Unsuccessful Implants     CRT-P: Biventricular Pacing Arm     CRT-P: Right Ventricular Pacing Arm     CRT-P: Not Randomized     CRT-D: Biventricular Pacing Arm     CRT-D: Right Ventricular Pacing Arm     CRT-D: Not Randomized  
STARTED     109     51     243     241     47     106     101     20  
COMPLETED     0     0     149     135     10     66     55     5  
NOT COMPLETED     109     51     94     106     37     40     46     15  
Death                 0                 0                 57                 66                 14                 23                 28                 9  
Lost to Follow-up                 0                 0                 6                 5                 2                 3                 1                 1  
Withdrawal by Subject                 8                 0                 24                 21                 12                 9                 12                 5  
Physician Decision                 5                 0                 7                 11                 5                 4                 3                 0  
Inclusion/Exclusion Criteria Not Met                 96                 0                 0                 0                 2                 0                 0                 0  
Unsuccessful Implant Exit Per Protocol                 0                 51                 0                 0                 0                 0                 0                 0  
Site closure                 0                 0                 0                 1                 0                 1                 1                 0  
Explanted Medtronic device                 0                 0                 0                 1                 0                 0                 0                 0  
Non-Medtronic LV Lead Implanted                 0                 0                 0                 0                 2                 0                 0                 0  
Subject listed for heart transplant                 0                 0                 0                 0                 0                 0                 1                 0  
Sponsor withdrew subject                 0                 0                 0                 1                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Implant Attempt Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
Unsuccessful Implants Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
CRT-P: Biventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
CRT-P: Right Ventricular Pacing Arm Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
CRT-P: Not Randomized Subjects successfully implanted with a CRT-P device who were not randomized
CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
CRT-D: Not Randomized Subjects successfully implanted with a CRT-D device who were not randomized
Total Total of all reporting groups

Baseline Measures
    No Implant Attempt     Unsuccessful Implants     CRT-P: Biventricular Pacing Arm     CRT-P: Right Ventricular Pacing Arm     CRT-P: Not Randomized     CRT-D: Biventricular Pacing Arm     CRT-D: Right Ventricular Pacing Arm     CRT-D: Not Randomized     Total  
Number of Participants  
[units: participants]
  109     51     243     241     47     106     101     20     918  
Age  
[units: years]
Mean ± Standard Deviation
  70.2  ± 12.6     71.1  ± 11.2     74.4  ± 10.2     73.8  ± 10.8     79.3  ± 7.6     72.0  ± 9.3     71.0  ± 10.0     74.0  ± 9.1     73.2  ± 10.6  
Gender  
[units: participants]
                 
Female     29     14     62     73     18     19     20     4     239  
Male     80     37     181     168     29     87     81     16     679  
Race/Ethnicity, Customized  
[units: participants]
                 
Subject did not offer ethnicity     6     2     6     5     1     4     3     0     27  
African American     10     3     8     10     0     4     4     1     40  
Asian     0     0     0     0     1     0     0     0     1  
Caucasian     91     45     225     224     43     96     90     18     832  
Hispanic     1     0     3     1     2     2     2     1     12  
Native American     0     0     0     1     0     0     0     0     1  
Other     1     1     1     0     0     0     2     0     5  
Region of Enrollment  
[units: participants]
                 
United States     109     46     232     231     47     104     98     19     886  
Canada     0     5     11     10     0     2     3     1     32  



  Outcome Measures
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1.  Primary:   Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Primary
Measure Title Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
Measure Description Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)  
[units: participants]
   
Subjects Experiencing a Primary Endpoint     160     191  
Subjects with an LVESVI Primary Endpoint     93     136  
Subjects with an HF Urgent Care Primary Endpoint     70     94  
Subjects who died     55     66  


Statistical Analysis 1 for Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.9990
Hazard Ratio (HR) [4] 0.729
95% Confidence Interval ( 0.592 to 0.889 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.



2.  Secondary:   All-Cause Mortality   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title All-Cause Mortality
Measure Description

The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared.

This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met).

Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
All-Cause Mortality  
[units: participants]
   
Subjects who died     80     94  
Subjects who did not die     269     248  


Statistical Analysis 1 for All-Cause Mortality
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.865
Hazard Ratio (HR) [4] 0.843
95% Confidence Interval ( 0.632 to 1.142 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.



3.  Secondary:   All-Cause Mortality or Heart Failure-related Hospitalization   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title All-Cause Mortality or Heart Failure-related Hospitalization
Measure Description The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
All-Cause Mortality or Heart Failure-related Hospitalization  
[units: participants]
   
Subjects who died or underwent HF hospitalization     121     135  
Subjects who died     80     94  
Subjects who underwent HF hospitalization     79     92  


Statistical Analysis 1 for All-Cause Mortality or Heart Failure-related Hospitalization
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.9785
Hazard Ratio (HR) [4] 0.781
95% Confidence Interval ( 0.615 to 0.991 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.



4.  Secondary:   All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index
Measure Description

The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization.

Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive.

Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index  
[units: participants]
   
Subjects who died or experienced LVESVI event     131     171  
Subjects who died     55     66  
Subjects who experienced LVESVI event     93     136  


Statistical Analysis 1 for All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.9886
Hazard Ratio (HR) [4] 0.695
95% Confidence Interval ( 0.558 to 0.866 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.



5.  Secondary:   First Heart Failure Hospitalization   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title First Heart Failure Hospitalization
Measure Description The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
First Heart Failure Hospitalization  
[units: participants]
   
Subjects experiencing a HF hospitalization     79     92  
Subjects not experiencing a HF hospitalization     270     250  


Statistical Analysis 1 for First Heart Failure Hospitalization
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.9904
Hazard Ratio (HR) [4] 0.704
95% Confidence Interval ( 0.522 to 0.947 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.



6.  Secondary:   Days Hospitalized for Heart Failure   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title Days Hospitalized for Heart Failure
Measure Description For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Days Hospitalized for Heart Failure  
[units: Days hospitalized per patient year]
Mean ± Standard Deviation
  1.89  ± 9.52     2.63  ± 16.08  


Statistical Analysis 1 for Days Hospitalized for Heart Failure
Groups [1] All groups
Method [2] Difference in Average Ranks
P Value [3] 0.637
BiV - RV Difference in Average Rank [4] -1.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.



7.  Secondary:   Change in New York Heart Association Classification   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in New York Heart Association Classification
Measure Description The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the "Comparative data not available" category for that time point.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Change in New York Heart Association Classification  
[units: participants]
   
6 Months: Improved by 2 classes from randomization     5     3  
6 Months: Improved by 1 class from randomization     54     43  
6 Months: No change from randomization     200     205  
6 Months: Worsened by 1 class from randomization     52     41  
6 Months: Worsened by 2 classes from randomization     1     1  
6 Months: Comparative data not available     37     49  
12 Months:Improved by 2 classes from randomization     4     5  
12 Months:Improved by 1 class from randomization     54     34  
12 Months: No change from randomization     172     172  
12 Months: Worsened by 1 class from randomization     49     64  
12 Months:Worsened by 2 classes from randomization     2     3  
12 Months: Comparative data not available     68     64  
18 Months:Improved by 2 classes from randomization     3     2  
18 Months: Improved by 1 class from randomization     43     45  
18 Months: No change from randomization     142     141  
18 Months: Worsened by 1 class from randomization     50     56  
18 Months:Worsened by 2 classes from randomization     4     6  
18 Months: Comparative data not available     107     92  
24 Months:Improved by 2 classes from randomization     2     3  
24 Months: Improved by 1 class from randomization     35     36  
24 Months: No change from randomization     135     126  
24 Months:Worsened by 1 class from randomization     41     54  
24 Months:Worsened by 2 classes from randomization     4     3  
24 Months: Comparative data not available     132     120  


Statistical Analysis 1 for Change in New York Heart Association Classification
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.591
BiV - RV Difference in Average Rank [4] 0.012
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.

Statistical Analysis 2 for Change in New York Heart Association Classification
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.986
BiV - RV Difference in Average Rank [4] 0.126
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.

Statistical Analysis 3 for Change in New York Heart Association Classification
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.726
BiV - RV Difference in Average Rank [4] 0.039
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.

Statistical Analysis 4 for Change in New York Heart Association Classification
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.701
BiV - RV Difference in Average Rank [4] 0.035
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.



8.  Secondary:   Change in Heart Failure Stage   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Heart Failure Stage
Measure Description The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the "Comparative data not available" category for that time point.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Change in Heart Failure Stage  
[units: participants]
   
6 Months: Improved by 2 stages since randomization     1     0  
6 Months: Improved by 1 stage since randomization     11     5  
6 Months: No change from randomization     296     274  
6 Months: Worsened by 1 stage since randomization     2     14  
6 Months: Worsened by 2 stages since randomization     1     0  
6 Months: Comparative data not available     38     49  
12 Months:Improved by 2 stages since randomization     0     0  
12 Months:Improved by 1 stage since randomization     7     8  
12 Months: No change since randomization     258     244  
12 Months: Worsened by 1 stage since randomization     15     23  
12 Months:Worsened by 2 stages since randomization     1     1  
12 Months: Comparative data not available     68     66  
18 Months:Improved by 2 stages since randomization     0     0  
18 Months:Improved by 1 stage since randomization     4     5  
18 Months: No change since randomization     222     225  
18 Months:Worsened by 1 stage since randomization     16     18  
18 Months:Worsened by 2 stages since randomization     0     1  
18 Months: Comparative data not available     107     93  
24 Months:Improved by 2 stages since randomization     0     0  
24 Months: Improved by 1 stage since randomization     4     6  
24 Months: No change since randomization     196     197  
24 Months:Worsened by 1 stage since randomization     16     19  
24 Months:Worsened by 2 stages since randomization     1     0  
24 Months: Comparative data not available     132     120  


Statistical Analysis 1 for Change in Heart Failure Stage
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.534
BiV - RV Difference in Average Rank [4] 0.002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.

Statistical Analysis 2 for Change in Heart Failure Stage
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.825
BiV - RV Difference in Average Rank [4] 0.026
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values reflect better outcomes over time in the BiV arm than the RV arm.

Statistical Analysis 3 for Change in Heart Failure Stage
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.651
BiV - RV Difference in Average Rank [4] 0.010
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values denote that the BiV arm had better outcomes over time than the RV arm.

Statistical Analysis 4 for Change in Heart Failure Stage
Groups [1] All groups
Method [2] Posterior Distribution for Average Rank
P Value [3] 0.425
BiV - RV Difference in Average Rank [4] -0.006
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  Positive values denote better outcomes over time in the BiV arm than the RV arm.



9.  Secondary:   Change in Cardiovascular Medications   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title Change in Cardiovascular Medications
Measure Description The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as "Subjects with Medications Assessed").

Reporting Groups
  Description
CRT-P: Biventricular Pacing Arm Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
CRT-P: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing

Measured Values
    CRT-P: Biventricular Pacing Arm     CRT-P: Right Ventricular Pacing Arm     CRT-D: Biventricular Pacing Arm     CRT-D: Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  243     241     106     101  
Change in Cardiovascular Medications  
[units: participants]
       
Randomization: Subjects on ACE-Inhibitors/ARBs     173     179     93     84  
Randomization: Subjects on Beta Blockers     186     191     98     93  
Randomization: Subjects on Vasodilators/Nitrates     53     44     31     20  
Randomization: Subjects on Aldosterone Antagonists     33     25     19     25  
Randomization: Subjects on Diuretics     156     158     74     74  
6 Months: Subjects with Medications Assessed     226     207     94     89  
6 Months: Subjects on ACE-Inhibitors/ARBs     162     152     77     73  
6 Months: Subjects on Beta Blockers     175     171     87     79  
6 Months: Subjects on Vasodilators/Nitrates     46     42     24     12  
6 Months: Subjects on Aldosterone Antagonists     31     21     20     25  
6 Months: Subjects on Diuretics     148     137     66     70  
12 Months: Subjects with Medications Assessed     205     200     83     81  
12 Months: Subjects on ACE-Inhibitors/ARBs     147     151     72     70  
12 Months: Subjects on Beta Blockers     158     170     79     75  
12 Months: Subjects on Vasodilators/Nitrates     45     43     22     13  
12 Months: Subjects on Aldosterone Antagonists     23     20     13     21  
12 Months: Subjects on Diuretics     133     131     57     60  
18 Months: Subjects with Medications Assessed     169     181     78     72  
18 Months: Subjects on ACE-Inhibitors/ARBs     121     137     62     58  
18 Months: Subjects on Beta Blockers     134     152     75     63  
18 Months: Subjects on Vasodilators/Nitrates     36     44     22     11  
18 Months: Subjects on Aldosterone Antagonists     16     21     9     20  
18 Months: Subjects on Diuretics     111     125     51     59  
24 Months: Subjects with Medications Assessed     152     157     69     67  
24 Months: Subjects on ACE-Inhibitors/ARBs     114     119     58     56  
24 Months: Subjects on Beta Blockers     118     133     65     63  
24 Months: Subjects on Vasodilators/Nitrates     28     37     23     10  
24 Months: Subjects on Aldosterone Antagonists     18     15     13     18  
24 Months: Subjects on Diuretics     97     104     47     56  
30 Months: Subjects with Medications Assessed     130     131     53     57  
30 Months: Subjects on ACE-Inhibitors/ARBs     92     102     42     47  
30 Months: Subjects on Beta Blockers     104     114     51     56  
30 Months: Subjects on Vasodilators/Nitrates     23     28     16     11  
30 Months: Subjects on Aldosterone Antagonists     14     14     10     15  
30 Months: Subjects on Diuretics     82     90     36     50  
36 Months: Subjects with Medications Assessed     109     112     42     44  
36 Months: Subjects on ACE-Inhibitors/ARBs     76     85     30     37  
36 Months: Subjects on Beta Blockers     86     97     41     44  
36 Months: Subjects on Vasodilators/Nitrates     21     24     14     9  
36 Months: Subjects on Aldosterone Antagonists     10     19     8     10  
36 Months: Subjects on Diuretics     69     79     34     37  
42 Months: Subjects with Medications Assessed     94     99     38     42  
42 Months: Subjects on ACE-Inhibitors/ARBs     69     73     27     35  
42 Months: Subjects on Beta Blockers     75     86     35     42  
42 Months: Subjects on Vasodilators/Nitrates     15     22     12     10  
42 Months: Subjects on Aldosterone Antagonists     8     13     9     12  
42 Months: Subjects on Diuretics     57     71     31     39  

No statistical analysis provided for Change in Cardiovascular Medications



10.  Secondary:   Frequency of Adverse Events Post-randomization   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title Frequency of Adverse Events Post-randomization
Measure Description Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CRT-P: Biventricular Pacing Arm Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
CRT-P: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing

Measured Values
    CRT-P: Biventricular Pacing Arm     CRT-P: Right Ventricular Pacing Arm     CRT-D: Biventricular Pacing Arm     CRT-D: Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  243     241     106     101  
Frequency of Adverse Events Post-randomization  
[units: participants]
       
Subjects with procedure-related AE(s)     37     7     7     2  
Subjects with system-related AE(s)     56     31     47     24  
Subjects with LV lead-related AE(s)     40     12     14     4  
Subjects with CRT-P/CRT-D related AE(s)     12     17     36     18  
Subjects with HF-related AE(s)     73     106     45     47  

No statistical analysis provided for Frequency of Adverse Events Post-randomization



11.  Secondary:   Cardiovascular-related Healthcare Utilizations   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

Measure Type Secondary
Measure Title Cardiovascular-related Healthcare Utilizations
Measure Description Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm
Time Frame Participants were followed for the duration of the study, an average of 39.8 months post-randomization.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Cardiovascular-related Healthcare Utilizations  
[units: participants]
   
Subjects with a post-randomization CV HCU     264     263  
Subjects with post-randomization hospitalization     164     162  
Subjects with post-randomization ED visit     118     128  
Subjects with post-randomization urgent care visit     12     12  
Subjects with post-randomization clinic visit     214     220  

No statistical analysis provided for Cardiovascular-related Healthcare Utilizations



12.  Secondary:   Change in Quality of Life at 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Quality of Life at 6 Months
Measure Description

The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.

Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  304     289  
Change in Quality of Life at 6 Months  
[units: units on a scale]
Mean ± Standard Deviation
  5  ± 20.3     0.3  ± 19.4  


Statistical Analysis 1 for Change in Quality of Life at 6 Months
Groups [1] All groups
Method [2] Posterior Probability of Mean QOL Change
P Value [3] 0.9976
Mean Difference (Final Values) [4] 4.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  No text entered.



13.  Secondary:   Change in Quality of Life at 12 Months   [ Time Frame: Randomization to 12 months ]

Measure Type Secondary
Measure Title Change in Quality of Life at 12 Months
Measure Description

The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.

Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Time Frame Randomization to 12 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  274     273  
Change in Quality of Life at 12 Months  
[units: units on a scale]
Mean ± Standard Deviation
  3.9  ± 20.1     0.9  ± 18.9  


Statistical Analysis 1 for Change in Quality of Life at 12 Months
Groups [1] All groups
Method [2] Posterior Probability of Mean QOL Change
P Value [3] 0.9641
Mean Difference (Final Values) [4] 3.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change in Quality of Life at 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Quality of Life at 18 Months
Measure Description

The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.

Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  237     244  
Change in Quality of Life at 18 Months  
[units: units on a scale]
Mean ± Standard Deviation
  2.3  ± 20.5     0.5  ± 18.1  


Statistical Analysis 1 for Change in Quality of Life at 18 Months
Groups [1] All groups
Method [2] Posterior Probability of Mean QOL Change
P Value [3] 0.8416
Mean Difference (Final Values) [4] 1.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  No text entered.



15.  Secondary:   Change in Quality of Life at 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Quality of Life at 24 Months
Measure Description

The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.

Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects.

Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  214     218  
Change in Quality of Life at 24 Months  
[units: units on a scale]
Mean ± Standard Deviation
  2.6  ± 20.5     1.5  ± 18.8  


Statistical Analysis 1 for Change in Quality of Life at 24 Months
Groups [1] All groups
Method [2] Posterior Probability of Mean QOL Change
P Value [3] 0.7270
Mean Difference (Final Values) [4] 1.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.
[4] Other relevant estimation information:
  No text entered.



16.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  282     273  
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months  
[units: percentage]
Mean ± Standard Deviation
  3.0  ± 8.4     -0.3  ± 8.9  


Statistical Analysis 1 for Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 3.334
95% Confidence Interval ( 1.886 to 4.815 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.



17.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  263     260  
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months  
[units: percentage]
Mean ± Standard Deviation
  2.7  ± 9.3     -0.5  ± 9.4  


Statistical Analysis 1 for Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 3.232
95% Confidence Interval ( 1.618 to 4.839 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.



18.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  223     226  
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months  
[units: percentage]
Mean ± Standard Deviation
  2.7  ± 9.5     0.4  ± 10.1  


Statistical Analysis 1 for Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 2.240
95% Confidence Interval ( 0.419 to 4.066 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.



19.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  192     205  
Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months  
[units: percentage]
Mean ± Standard Deviation
  2.0  ± 9.6     -1.6  ± 10.5  


Statistical Analysis 1 for Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 3.623
95% Confidence Interval ( 1.623 to 5.604 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.



20.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  279     272  
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -6.8  ± 17.1     0.4  ± 17.7  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -7.204
95% Confidence Interval ( -10.12 to -4.214 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.



21.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  260     256  
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -6.8  ± 18.7     0.5  ± 20.2  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -7.255
95% Confidence Interval ( -10.590 to -3.829 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.



22.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  219     225  
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -8.8  ± 18.9     -0.5  ± 19.9  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -8.242
95% Confidence Interval ( -11.860 to -4.574 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.



23.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  187     204  
Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -6.0  ± 22.6     1.4  ± 21.3  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -7.268
95% Confidence Interval ( -11.690 to -2.846 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.



24.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  281     273  
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -6.2  ± 19.2     -0.3  ± 19.5  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -5.858
95% Confidence Interval ( -9.085 to -2.562 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.



25.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  261     256  
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -7.0  ± 20.6     -1.1  ± 22.2  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -5.807
95% Confidence Interval ( -9.467 to -2.038 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.



26.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  220     225  
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -9.8  ± 21.4     -0.8  ± 22.4  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -8.844
95% Confidence Interval ( -12.910 to -4.681 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.

This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.



27.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  189     206  
Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months  
[units: ml/square meter of body surface area]
Mean ± Standard Deviation
  -6.9  ± 24.9     -0.1  ± 23.7  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -6.615
95% Confidence Interval ( -11.370 to -1.736 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.



28.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  220     208  
Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months  
[units: grams]
Mean ± Standard Deviation
  -8.4  ± 43.1     -4.2  ± 47.5  


Statistical Analysis 1 for Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -3.894
95% Confidence Interval ( -12.130 to 3.953 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.



29.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  211     199  
Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months  
[units: grams]
Mean ± Standard Deviation
  -15.8  ± 46.8     -4.7  ± 52.4  


Statistical Analysis 1 for Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -10.160
95% Confidence Interval ( -19.330 to -0.857 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.



30.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  168     176  
Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months  
[units: grams]
Mean ± Standard Deviation
  -16.8  ± 48.8     -7.2  ± 49.8  


Statistical Analysis 1 for Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -8.316
95% Confidence Interval ( -18.190 to 1.623 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.



31.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  150     163  
Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months  
[units: grams]
Mean ± Standard Deviation
  -19.4  ± 45.1     -6.8  ± 49.6  


Statistical Analysis 1 for Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -11.080
95% Confidence Interval ( -21.110 to -0.956 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.



32.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  254     242  
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months  
[units: cm]
Mean ± Standard Deviation
  -0.1  ± 0.6     0.0  ± 0.6  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.126
95% Confidence Interval ( -0.235 to -0.014 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.



33.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  241     232  
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months  
[units: cm]
Mean ± Standard Deviation
  -0.1  ± 0.7     0.0  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.162
95% Confidence Interval ( -0.287 to -0.035 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.



34.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  201     204  
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months  
[units: cm]
Mean ± Standard Deviation
  -0.2  ± 0.6     0.0  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.163
95% Confidence Interval ( -0.293 to -0.030 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.



35.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  175     186  
Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months  
[units: cm]
Mean ± Standard Deviation
  -0.3  ± 0.7     0.0  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.245
95% Confidence Interval ( -0.390 to -0.097 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.



36.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  250     241  
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months  
[units: cm]
Mean ± Standard Deviation
  -0.1  ± 0.6     0.0  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.066
95% Confidence Interval ( -0.185 to 0.055 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.



37.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  239     231  
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months  
[units: cm]
Mean ± Standard Deviation
  0.0  ± 0.7     0.1  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.104
95% Confidence Interval ( -0.236 to 0.029 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.



38.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  199     204  
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months  
[units: cm]
Mean ± Standard Deviation
  -0.1  ± 0.7     0.0  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.060
95% Confidence Interval ( -0.204 to 0.087 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.



39.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  173     185  
Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months  
[units: cm]
Mean ± Standard Deviation
  -0.1  ± 0.8     0.1  ± 0.7  


Statistical Analysis 1 for Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.180
95% Confidence Interval ( -0.339 to -0.018 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.



40.  Secondary:   Change in Mitral Regurgitation From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Mitral Regurgitation From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  247     225  
Change in Mitral Regurgitation From Randomization to 6 Months  
[units: percentage of left atrial area]
Mean ± Standard Deviation
  -1.3  ± 12.4     -0.6  ± 11.2  


Statistical Analysis 1 for Change in Mitral Regurgitation From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.683
95% Confidence Interval ( -2.828 to 1.506 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.



41.  Secondary:   Change in Mitral Regurgitation From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Mitral Regurgitation From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  235     214  
Change in Mitral Regurgitation From Randomization to 12 Months  
[units: percentage of left atrial area]
Mean ± Standard Deviation
  -1.3  ± 12.0     -0.8  ± 12.6  


Statistical Analysis 1 for Change in Mitral Regurgitation From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.564
95% Confidence Interval ( -2.843 to 1.773 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.



42.  Secondary:   Change in Mitral Regurgitation From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Mitral Regurgitation From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  188     195  
Change in Mitral Regurgitation From Randomization to 18 Months  
[units: percentage of left atrial area]
Mean ± Standard Deviation
  -1.9  ± 12.1     -1.9  ± 11.5  


Statistical Analysis 1 for Change in Mitral Regurgitation From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.016
95% Confidence Interval ( -2.379 to 2.425 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.



43.  Secondary:   Change in Mitral Regurgitation From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Mitral Regurgitation From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  173     173  
Change in Mitral Regurgitation From Randomization to 24 Months  
[units: percentage of left atrial area]
Mean ± Standard Deviation
  -1.1  ± 13.6     -0.5  ± 11.4  


Statistical Analysis 1 for Change in Mitral Regurgitation From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.653
95% Confidence Interval ( -3.337 to 2.046 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.



44.  Secondary:   Change in Cardiac Index From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Cardiac Index From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  275     268  
Change in Cardiac Index From Randomization to 6 Months  
[units: liters per minute per squared meter]
Mean ± Standard Deviation
  0  ± 0.6     -0.1  ± 0.7  


Statistical Analysis 1 for Change in Cardiac Index From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.080
95% Confidence Interval ( -0.031 to 0.195 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.



45.  Secondary:   Change in Cardiac Index From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Cardiac Index From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  257     250  
Change in Cardiac Index From Randomization to 12 Months  
[units: liters per minute per squared meter]
Mean ± Standard Deviation
  -0.1  ± 0.6     -0.2  ± 0.6  


Statistical Analysis 1 for Change in Cardiac Index From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.086
95% Confidence Interval ( -0.022 to 0.198 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.



46.  Secondary:   Change in Cardiac Index From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Cardiac Index From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  215     218  
Change in Cardiac Index From Randomization to 18 Months  
[units: liters per minute per squared meter]
Mean ± Standard Deviation
  -0.1  ± 0.7     0  ± 0.7  


Statistical Analysis 1 for Change in Cardiac Index From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.081
95% Confidence Interval ( -0.218 to 0.058 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.



47.  Secondary:   Change in Cardiac Index From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Cardiac Index From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  186     198  
Change in Cardiac Index From Randomization to 24 Months  
[units: liters per minute per squared meter]
Mean ± Standard Deviation
  -0.1  ± 0.7     -0.2  ± 0.7  


Statistical Analysis 1 for Change in Cardiac Index From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.047
95% Confidence Interval ( -0.095 to 0.192 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.



48.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  220     208  
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months  
[units: ms]
Mean ± Standard Deviation
  49.9  ± 134.2     -4.2  ± 136.1  


Statistical Analysis 1 for Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 29.300
95% Confidence Interval ( 10.040 to 48.640 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.



49.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  202     198  
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months  
[units: ms]
Mean ± Standard Deviation
  38.5  ± 121.9     0.4  ± 128.9  


Statistical Analysis 1 for Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 21.830
95% Confidence Interval ( 2.841 to 40.870 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.



50.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  173     172  
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months  
[units: ms]
Mean ± Standard Deviation
  55.1  ± 135.7     -0.8  ± 136.7  


Statistical Analysis 1 for Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 26.530
95% Confidence Interval ( 6.247 to 47.190 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.



51.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  150     160  
Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months  
[units: ms]
Mean ± Standard Deviation
  48.6  ± 138.1     -4.9  ± 133.3  


Statistical Analysis 1 for Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 23.32
95% Confidence Interval ( 1.999 to 44.530 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.



52.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months
Measure Description The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  221     194  
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months  
[units: ratio]
Mean ± Standard Deviation
  0  ± 0.6     0  ± 0.7  


Statistical Analysis 1 for Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.047
95% Confidence Interval ( -0.180 to 0.089 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.



53.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months
Measure Description The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  208     188  
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months  
[units: ratio]
Mean ± Standard Deviation
  0.1  ± 0.7     0.2  ± 1.0  


Statistical Analysis 1 for Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] -0.117
95% Confidence Interval ( -0.287 to 0.058 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.



54.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months
Measure Description The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  174     159  
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months  
[units: ratio]
Mean ± Standard Deviation
  0.1  ± 0.8     0.1  ± 0.8  


Statistical Analysis 1 for Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.041
95% Confidence Interval ( -0.136 to 0.220 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.



55.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months
Measure Description The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  160     141  
Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months  
[units: ratio]
Mean ± Standard Deviation
  0.2  ± 0.8     0.1  ± 0.9  


Statistical Analysis 1 for Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months
Groups [1] All groups
Method [2] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [3] 0.110
95% Confidence Interval ( -0.085 to 0.311 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.



56.  Secondary:   Clinical Composite Score at 6 Months   [ Time Frame: Randomization to 6 Months ]

Measure Type Secondary
Measure Title Clinical Composite Score at 6 Months
Measure Description The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame Randomization to 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing.

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  349     342  
Clinical Composite Score at 6 Months  
[units: participants]
   
Improved     184     133  
Unchanged     83     113  
Worsened     82     96  


Statistical Analysis 1 for Clinical Composite Score at 6 Months
Groups [1] All groups
Method [2] Posterior probability of mean difference
P Value [3] 0.9985
Mean Difference (Final Values) [4] 0.1841
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior probability that the mean difference is greater than 0 was calculated.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.



57.  Secondary:   Clinical Composite Score at 12 Months   [ Time Frame: Randomization to 12 Months ]

Measure Type Secondary
Measure Title Clinical Composite Score at 12 Months
Measure Description The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame Randomization to 12 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  345     341  
Clinical Composite Score at 12 Months  
[units: participants]
   
Improved     160     117  
Unchanged     82     78  
Worsened     103     146  


Statistical Analysis 1 for Clinical Composite Score at 12 Months
Groups [1] All groups
Method [2] Posterior probability of mean difference
P Value [3] 0.9999
Mean Difference (Final Values) [4] 0.2503
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior probability that the mean difference is greater than 0 was calculated.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.



58.  Secondary:   Clinical Composite Score at 18 Months   [ Time Frame: Randomization to 18 Months ]

Measure Type Secondary
Measure Title Clinical Composite Score at 18 Months
Measure Description The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame Randomization to 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  325     323  
Clinical Composite Score at 18 Months  
[units: participants]
   
Improved     137     103  
Unchanged     68     70  
Worsened     120     150  


Statistical Analysis 1 for Clinical Composite Score at 18 Months
Groups [1] All groups
Method [2] Posterior probability of mean difference
P Value [3] 0.9978
Mean Difference (Final Values) [4] 0.1978
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior probability that the mean difference is greater than 0 was calculated.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.



59.  Secondary:   Clinical Composite Score at 24 Months   [ Time Frame: Randomization to 24 Months ]

Measure Type Secondary
Measure Title Clinical Composite Score at 24 Months
Measure Description The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.
Time Frame Randomization to 24 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-P: Not Randomized", and "CRT-D: Not Randomized" subgroups were excluded.

Reporting Groups
  Description
Biventricular Pacing Arm Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
Right Ventricular Pacing Arm Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure

Measured Values
    Biventricular Pacing Arm     Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  308     314  
Clinical Composite Score at 24 Months  
[units: participants]
   
Improved     118     94  
Unchanged     70     59  
Worsened     120     161  


Statistical Analysis 1 for Clinical Composite Score at 24 Months
Groups [1] All groups
Method [2] Posterior probability of mean difference
P Value [3] 0.9983
Mean Difference (Final Values) [4] 0.2069
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior probability that the mean difference is greater than 0 was calculated.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.



60.  Secondary:   CRT-P and CRT-D System Implant Success   [ Time Frame: Initial Implant Procedure ]

Measure Type Secondary
Measure Title CRT-P and CRT-D System Implant Success
Measure Description The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.
Time Frame Initial Implant Procedure  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For this outcome measure, only subjects in the "No Implant Attempt" subgroup were excluded.

Reporting Groups
  Description
Subjects With a CRT-P Implant Attempt Subjects who underwent an implant attempt for a CRT-P device
Subjects With a CRT-D Implant Attempt Subjects who underwent an implant attempt for a CRT-D device

Measured Values
    Subjects With a CRT-P Implant Attempt     Subjects With a CRT-D Implant Attempt  
Number of Participants Analyzed  
[units: participants]
  561     248  
CRT-P and CRT-D System Implant Success  
[units: participants]
   
Subjects successfully implanted     531     227  
Subjects not successfully implanted     30     21  

No statistical analysis provided for CRT-P and CRT-D System Implant Success



61.  Secondary:   Incidence of Ventricular Tachyarrhythmias   [ Time Frame: Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects. ]

Measure Type Secondary
Measure Title Incidence of Ventricular Tachyarrhythmias
Measure Description Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.
Time Frame Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the "No Implant Attempt", "Unsuccessful Implants", "CRT-D: Not Randomized", and all CRT-P subgroups were excluded.

Reporting Groups
  Description
CRT-D: Biventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
CRT-D: Right Ventricular Pacing Arm Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing

Measured Values
    CRT-D: Biventricular Pacing Arm     CRT-D: Right Ventricular Pacing Arm  
Number of Participants Analyzed  
[units: participants]
  106     101  
Incidence of Ventricular Tachyarrhythmias  
[units: participants]
   
Subjects who experienced VT/VF     39     31  
Subjects who did not experience VT/VF     67     70  


Statistical Analysis 1 for Incidence of Ventricular Tachyarrhythmias
Groups [1] All groups
Method [2] Posterior Distribution for HR
P Value [3] 0.189
Hazard Ratio (HR) [4] 1.23
95% Confidence Interval ( 0.78 to 2.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.
[4] Other relevant estimation information:
  The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: BLOCK HF Clinical Trial Leader
Organization: Medtronic CRDM Clinical
phone: 763-526-2729
e-mail: medtroniccrmtrials@medtronic.com


No publications provided by Medtronic Cardiac Rhythm Disease Management

Publications automatically indexed to this study:

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00267098     History of Changes
Other Study ID Numbers: 215
Study First Received: December 19, 2005
Results First Received: December 18, 2013
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration