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

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ClinicalTrials.gov Identifier: NCT00267098
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrioventricular Block
Heart Diseases
Intervention: Device: Cardiac Resynchronization Therapy (CRT)

  Participant Flow

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

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

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. ]
  Show Outcome Measure 2

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. ]
  Show Outcome Measure 3

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. ]
  Show Outcome Measure 4

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. ]
  Show Outcome Measure 5

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. ]
  Show Outcome Measure 6

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

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

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 ]
  Show Outcome Measure 12

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

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

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

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

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  

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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Bayesian Credible Interval
Posterior BiV - RV Mean Difference [4] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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 ]
  Show Outcome Measure 20

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 40

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 56

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

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

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

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

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


  Other Adverse Events


  Limitations and Caveats

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


  More Information

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
First Submitted: December 19, 2005
First Posted: December 20, 2005
Results First Submitted: December 18, 2013
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014