Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

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

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

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

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

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



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

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

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



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

2.  Secondary:   All-Cause Mortality   [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]
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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. ]
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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. ]
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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. ]
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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. ]
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7.  Secondary:   Change in New York Heart Association Classification   [ Time Frame: Randomization to 24 Months ]
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8.  Secondary:   Change in Heart Failure Stage   [ Time Frame: Randomization to 24 Months ]
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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. ]
  Show Outcome Measure 9

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. ]
  Show Outcome Measure 10

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. ]
  Show Outcome Measure 11

12.  Secondary:   Change in Quality of Life at 6 Months   [ Time Frame: Randomization to 6 Months ]
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13.  Secondary:   Change in Quality of Life at 12 Months   [ Time Frame: Randomization to 12 months ]
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14.  Secondary:   Change in Quality of Life at 18 Months   [ Time Frame: Randomization to 18 Months ]
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15.  Secondary:   Change in Quality of Life at 24 Months   [ Time Frame: Randomization to 24 Months ]
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16.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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17.  Secondary:   Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
  Show Outcome Measure 17

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

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

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

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

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


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



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

20.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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21.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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22.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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23.  Secondary:   Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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24.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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25.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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26.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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27.  Secondary:   Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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28.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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29.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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30.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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31.  Secondary:   Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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32.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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33.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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34.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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35.  Secondary:   Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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36.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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37.  Secondary:   Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
  Show Outcome Measure 37

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

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

40.  Secondary:   Change in Mitral Regurgitation From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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41.  Secondary:   Change in Mitral Regurgitation From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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42.  Secondary:   Change in Mitral Regurgitation From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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43.  Secondary:   Change in Mitral Regurgitation From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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44.  Secondary:   Change in Cardiac Index From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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45.  Secondary:   Change in Cardiac Index From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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46.  Secondary:   Change in Cardiac Index From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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47.  Secondary:   Change in Cardiac Index From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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48.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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49.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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50.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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51.  Secondary:   Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
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52.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months   [ Time Frame: Randomization to 6 Months ]
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53.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months   [ Time Frame: Randomization to 12 Months ]
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54.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months   [ Time Frame: Randomization to 18 Months ]
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55.  Secondary:   Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months   [ Time Frame: Randomization to 24 Months ]
  Show Outcome Measure 55

56.  Secondary:   Clinical Composite Score at 6 Months   [ Time Frame: Randomization to 6 Months ]
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57.  Secondary:   Clinical Composite Score at 12 Months   [ Time Frame: Randomization to 12 Months ]
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58.  Secondary:   Clinical Composite Score at 18 Months   [ Time Frame: Randomization to 18 Months ]
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59.  Secondary:   Clinical Composite Score at 24 Months   [ Time Frame: Randomization to 24 Months ]
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60.  Secondary:   CRT-P and CRT-D System Implant Success   [ Time Frame: Initial Implant Procedure ]
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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. ]
  Show Outcome Measure 61


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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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  More Information
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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


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