Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
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 
Overall Participants Analyzed 
[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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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


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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
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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
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