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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;   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
  Show All 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. ]

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

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. ]

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. ]

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. ]

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. ]

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

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

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. ]

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. ]

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. ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Reported Adverse Events (AEs) include events starting on or after the date of consent and on or before the date of exit
Additional Description If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. In the case of the BiV and RV randomized arms, both pre-randomization and post-randomization adverse events are included.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Biventricular Pacing Arm   Right Ventricular Pacing Arm   CRT: Not Randomized   Unsuccessful Implants   No Implant Attempt
Total, Other (not including serious) Adverse Events           
# participants affected / at risk   193/349 (55.30%)   181/342 (52.92%)   16/67 (23.88%)   8/51 (15.69%)   0/109 (0.00%) 
Cardiac disorders           
Atrial fibrillation           
# participants affected / at risk   38/349 (10.89%)   33/342 (9.65%)   1/67 (1.49%)   0/51 (0.00%)   0/109 (0.00%) 
# events   42   36   1   0   0 
Cardiac failure           
# participants affected / at risk   63/349 (18.05%)   77/342 (22.51%)   2/67 (2.99%)   0/51 (0.00%)   0/109 (0.00%) 
# events   90   114   2   0   0 
General disorders           
Adverse drug reaction           
# participants affected / at risk   25/349 (7.16%)   20/342 (5.85%)   0/67 (0.00%)   1/51 (1.96%)   0/109 (0.00%) 
# events   30   23   0   1   0 
Chest pain           
# participants affected / at risk   19/349 (5.44%)   24/342 (7.02%)   0/67 (0.00%)   0/51 (0.00%)   0/109 (0.00%) 
# events   22   27   0   0   0 
Fatigue           
# participants affected / at risk   12/349 (3.44%)   17/342 (4.97%)   1/67 (1.49%)   0/51 (0.00%)   0/109 (0.00%) 
# events   13   17   1   0   0 
Infections and infestations           
Bronchitis           
# participants affected / at risk   17/349 (4.87%)   23/342 (6.73%)   0/67 (0.00%)   1/51 (1.96%)   0/109 (0.00%) 
# events   20   27   0   1   0 
Urinary tract infection           
# participants affected / at risk   29/349 (8.31%)   23/342 (6.73%)   5/67 (7.46%)   0/51 (0.00%)   0/109 (0.00%) 
# events   41   32   6   0   0 
Injury, poisoning and procedural complications           
Cardiac procedure complication           
# participants affected / at risk   4/349 (1.15%)   1/342 (0.29%)   1/67 (1.49%)   4/51 (7.84%)   0/109 (0.00%) 
# events   4   1   1   4   0 
Inappropriate device stimulation of tissue           
# participants affected / at risk   53/349 (15.19%)   14/342 (4.09%)   5/67 (7.46%)   1/51 (1.96%)   0/109 (0.00%) 
# events   70   14   6   1   0 
Metabolism and nutrition disorders           
Dehydration           
# participants affected / at risk   12/349 (3.44%)   19/342 (5.56%)   3/67 (4.48%)   0/51 (0.00%)   0/109 (0.00%) 
# events   14   22   3   0   0 
Nervous system disorders           
Dizziness           
# participants affected / at risk   12/349 (3.44%)   26/342 (7.60%)   1/67 (1.49%)   0/51 (0.00%)   0/109 (0.00%) 
# events   12   27   1   0   0 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea           
# participants affected / at risk   19/349 (5.44%)   29/342 (8.48%)   0/67 (0.00%)   1/51 (1.96%)   0/109 (0.00%) 
# events   19   30   0   1   0 
* Events were collected by non-systematic assessment



  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


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