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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
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. ]

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
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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.

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

Serious Adverse Events
    Biventricular Pacing Arm     Right Ventricular Pacing Arm     CRT: Not Randomized     Unsuccessful Implants     No Implant Attempt  
Total, serious adverse events            
# participants affected / at risk     223/349 (63.90%)     219/342 (64.04%)     41/67 (61.19%)     6/51 (11.76%)     2/109 (1.83%)  
Blood and lymphatic system disorders            
Anaemia *          
# participants affected / at risk     3/349 (0.86%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     5     0     0     0  
Anaemia of chronic disease *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     0     0     0     0  
Coagulopathy *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Lymphadenitis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Cardiac disorders            
Acute coronary syndrome *          
# participants affected / at risk     8/349 (2.29%)     8/342 (2.34%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     11     8     1     0     0  
Acute myocardial infarction *          
# participants affected / at risk     7/349 (2.01%)     3/342 (0.88%)     2/67 (2.99%)     0/51 (0.00%)     0/109 (0.00%)  
# events     7     3     2     0     0  
Angina pectoris *          
# participants affected / at risk     9/349 (2.58%)     10/342 (2.92%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     10     11     1     0     0  
Angina unstable *          
# participants affected / at risk     5/349 (1.43%)     6/342 (1.75%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     7     7     0     0     0  
Aortic valve incompetence *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Atrial fibrillation *          
# participants affected / at risk     14/349 (4.01%)     26/342 (7.60%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     19     37     1     0     0  
Atrial flutter *          
# participants affected / at risk     4/349 (1.15%)     4/342 (1.17%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     6     6     0     0     0  
Atrial tachycardia *          
# participants affected / at risk     0/349 (0.00%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     1     0     0  
Cardiac arrest *          
# participants affected / at risk     5/349 (1.43%)     6/342 (1.75%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     5     6     1     0     0  
Cardiac failure *          
# participants affected / at risk     100/349 (28.65%)     117/342 (34.21%)     20/67 (29.85%)     2/51 (3.92%)     0/109 (0.00%)  
# events     196     215     28     2     0  
Cardiac tamponade *          
# participants affected / at risk     4/349 (1.15%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     0     1     0     0  
Cardiac valve disease *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Cardio-respiratory arrest *          
# participants affected / at risk     2/349 (0.57%)     3/342 (0.88%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     3     1     0     0  
Cardiomyopathy *          
# participants affected / at risk     1/349 (0.29%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     3     0     0     0  
Coronary artery disease *          
# participants affected / at risk     10/349 (2.87%)     6/342 (1.75%)     1/67 (1.49%)     0/51 (0.00%)     1/109 (0.92%)  
# events     10     7     2     0     1  
Intracardiac thrombus *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     1/109 (0.92%)  
# events     1     0     1     0     1  
Mitral valve incompetence *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     1     0     0  
Myocardial infarction *          
# participants affected / at risk     1/349 (0.29%)     6/342 (1.75%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     6     0     0     0  
Pericardial effusion *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Stress cardiomyopathy *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Supraventricular tachycardia *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Tachycardia *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Ventricular arrhythmia *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Ventricular fibrillation *          
# participants affected / at risk     5/349 (1.43%)     7/342 (2.05%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     6     7     0     0     0  
Ventricular tachycardia *          
# participants affected / at risk     11/349 (3.15%)     14/342 (4.09%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     17     20     3     0     0  
Eye disorders            
Amaurosis fugax *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     2     0     0     0  
Gastrointestinal disorders            
Gastritis atrophic *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Gastrointestinal haemorrhage *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Pancreatitis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Retroperitoneal haemorrhage *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
General disorders            
Adverse drug reaction *          
# participants affected / at risk     5/349 (1.43%)     7/342 (2.05%)     0/67 (0.00%)     1/51 (1.96%)     0/109 (0.00%)  
# events     5     8     0     1     0  
Asthenia *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Chest discomfort *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Chest pain *          
# participants affected / at risk     3/349 (0.86%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     5     0     0     0  
Implant site erosion *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Implant site haematoma *          
# participants affected / at risk     1/349 (0.29%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     2     0     0     0  
Implant site pain *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Multi-organ failure *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Non-cardiac chest pain *          
# participants affected / at risk     2/349 (0.57%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     0     0     0     0  
Oedema peripheral *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Sudden death *          
# participants affected / at risk     1/349 (0.29%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     2     0     0     0  
Immune system disorders            
Sarcoidosis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Infections and infestations            
Bacteraemia *          
# participants affected / at risk     2/349 (0.57%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     0     0     0     0  
Bacterial pyelonephritis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Bronchitis *          
# participants affected / at risk     4/349 (1.15%)     4/342 (1.17%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     4     1     0     0  
Cellulitis *          
# participants affected / at risk     1/349 (0.29%)     4/342 (1.17%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     4     0     0     0  
Device related infection *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     2/67 (2.99%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     2     0     0  
Diabetic foot infection *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Endocarditis *          
# participants affected / at risk     1/349 (0.29%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     2     1     0     0  
Escherichia bacteraemia *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Gangrene *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Implant site cellulitis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Implant site infection *          
# participants affected / at risk     2/349 (0.57%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     2     1     0     0  
Klebsiella infection *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Lower respiratory tract infection *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Lung infection *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Osteomyelitis *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     2     0     0     0  
Osteomyelitis chronic *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pneumonia *          
# participants affected / at risk     28/349 (8.02%)     37/342 (10.82%)     6/67 (8.96%)     0/51 (0.00%)     0/109 (0.00%)  
# events     57     50     8     0     0  
Pyelonephritis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Sepsis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Sepsis syndrome *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Septic shock *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     1     0     0  
Staphylococcal sepsis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     1     0     0  
Urinary tract infection *          
# participants affected / at risk     7/349 (2.01%)     6/342 (1.75%)     2/67 (2.99%)     0/51 (0.00%)     0/109 (0.00%)  
# events     9     6     2     0     0  
Urosepsis *          
# participants affected / at risk     4/349 (1.15%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     2     0     0     0  
Vaginitis bacterial *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Injury, poisoning and procedural complications            
Arterial injury *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Arteriovenous fistula site complication *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Arteriovenous fistula site haemorrhage *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Arteriovenous fistula thrombosis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Arteriovenous graft thrombosis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Cardiac procedure complication *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Cervical vertebral fracture *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Complication of device insertion *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Defibrillation threshold increased *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Device failure *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Device lead damage *          
# participants affected / at risk     3/349 (0.86%)     3/342 (0.88%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     3     1     0     0  
Device migration *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Dialysis device complication *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Elevated pacing threshold *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Failure to capture *          
# participants affected / at risk     2/349 (0.57%)     4/342 (1.17%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     4     0     0     0  
Inappropriate device stimulation of tissue *          
# participants affected / at risk     6/349 (1.72%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     6     1     1     0     0  
Lead dislodgement *          
# participants affected / at risk     12/349 (3.44%)     13/342 (3.80%)     3/67 (4.48%)     3/51 (5.88%)     0/109 (0.00%)  
# events     13     15     3     3     0  
Lower limb fracture *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Oversensing *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pacemaker complication *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pneumothorax traumatic *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Post procedural haemorrhage *          
# participants affected / at risk     0/349 (0.00%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     0     0     0  
Procedural hypotension *          
# participants affected / at risk     2/349 (0.57%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     2     0     0     0  
Subdural haematoma *          
# participants affected / at risk     1/349 (0.29%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     3     0     0     0  
Investigations            
Ejection fraction decreased *          
# participants affected / at risk     1/349 (0.29%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     3     0     0     0  
Metabolism and nutrition disorders            
Dehydration *          
# participants affected / at risk     14/349 (4.01%)     13/342 (3.80%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     16     14     1     0     0  
Diabetic foot *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     0     0     0     0  
Failure to thrive *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Hyperkalaemia *          
# participants affected / at risk     2/349 (0.57%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     2     0     0     0  
Hypokalaemia *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Hyponatraemia *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)            
Bladder cancer *          
# participants affected / at risk     1/349 (0.29%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     2     0     0     0  
Bronchial carcinoma *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Laryngeal cancer *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Lung adenocarcinoma *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Lung cancer metastatic *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Lung neoplasm malignant *          
# participants affected / at risk     0/349 (0.00%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     0     0     0  
Non-small cell lung cancer *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Prostate cancer *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Prostate cancer metastatic *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Renal cell carcinoma stage unspecified *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     0     0     0  
Small cell lung cancer stage unspecified *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Ureteric cancer *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Nervous system disorders            
Aphasia *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Carotid artery disease *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Carotid artery stenosis *          
# participants affected / at risk     2/349 (0.57%)     4/342 (1.17%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     4     0     0     0  
Cerebral artery embolism *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Cerebral haemorrhage *          
# participants affected / at risk     3/349 (0.86%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     0     0     0     0  
Cerebrovascular accident *          
# participants affected / at risk     10/349 (2.87%)     14/342 (4.09%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     12     16     0     0     0  
Convulsion *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Encephalopathy *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Haemorrhage intracranial *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Intraventricular haemorrhage *          
# participants affected / at risk     0/349 (0.00%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     3     0     0     0  
Ischaemic stroke *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Presyncope *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Syncope *          
# participants affected / at risk     3/349 (0.86%)     8/342 (2.34%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     9     1     0     0  
Transient ischaemic attack *          
# participants affected / at risk     4/349 (1.15%)     7/342 (2.05%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     7     0     0     0  
Psychiatric disorders            
Confusional state *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Renal and urinary disorders            
Bladder obstruction *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Calculus bladder *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Calculus ureteric *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Calculus urinary *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Cystitis glandularis *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Haematuria *          
# participants affected / at risk     4/349 (1.15%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     1     0     0     0  
Nephrolithiasis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Obstructive uropathy *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Renal artery stenosis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Renal cyst *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Renal failure *          
# participants affected / at risk     4/349 (1.15%)     6/342 (1.75%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     4     6     0     0     0  
Renal failure acute *          
# participants affected / at risk     18/349 (5.16%)     15/342 (4.39%)     3/67 (4.48%)     0/51 (0.00%)     0/109 (0.00%)  
# events     20     17     4     0     0  
Renal failure chronic *          
# participants affected / at risk     5/349 (1.43%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     5     1     1     0     0  
Renal infarct *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Urinary retention *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     1     0     0  
Respiratory, thoracic and mediastinal disorders            
Acute respiratory failure *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     1     0     0  
Asthma *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Chronic obstructive pulmonary disease *          
# participants affected / at risk     17/349 (4.87%)     11/342 (3.22%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     23     17     1     0     0  
Dyspnoea *          
# participants affected / at risk     1/349 (0.29%)     5/342 (1.46%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     6     0     0     0  
Dyspnoea exertional *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Epistaxis *          
# participants affected / at risk     2/349 (0.57%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     5     0     0     0     0  
Haemopneumothorax *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     1/51 (1.96%)     0/109 (0.00%)  
# events     1     1     0     1     0  
Haemoptysis *          
# participants affected / at risk     0/349 (0.00%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     1     0     0  
Hypoxia *          
# participants affected / at risk     0/349 (0.00%)     2/342 (0.58%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     2     0     0     0  
Interstitial lung disease *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Mediastinal mass *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pneumonia aspiration *          
# participants affected / at risk     5/349 (1.43%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     5     2     1     0     0  
Pneumothorax *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pulmonary embolism *          
# participants affected / at risk     3/349 (0.86%)     2/342 (0.58%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     3     1     0     0  
Pulmonary mass *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Pulmonary oedema *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Respiratory arrest *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Respiratory failure *          
# participants affected / at risk     5/349 (1.43%)     6/342 (1.75%)     2/67 (2.99%)     0/51 (0.00%)     0/109 (0.00%)  
# events     5     6     2     0     0  
Skin and subcutaneous tissue disorders            
Drug eruption *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Skin ulcer *          
# participants affected / at risk     2/349 (0.57%)     4/342 (1.17%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     5     1     0     0  
Surgical and medical procedures            
Cardiac pacemaker insertion *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Medical device change *          
# participants affected / at risk     39/349 (11.17%)     23/342 (6.73%)     3/67 (4.48%)     0/51 (0.00%)     0/109 (0.00%)  
# events     39     24     3     0     0  
Medical device implantation *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     0     1     0     0  
Vascular disorders            
Aortic aneurysm *          
# participants affected / at risk     2/349 (0.57%)     3/342 (0.88%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     3     0     0     0  
Aortic arteriosclerosis *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Aortic stenosis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     2/67 (2.99%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     2     0     0  
Arterial occlusive disease *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Deep vein thrombosis *          
# participants affected / at risk     3/349 (0.86%)     4/342 (1.17%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     4     1     0     0  
Femoral artery occlusion *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Haematoma *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Haemorrhage *          
# participants affected / at risk     0/349 (0.00%)     0/342 (0.00%)     1/67 (1.49%)     1/51 (1.96%)     0/109 (0.00%)  
# events     0     0     1     1     0  
Hypertensive crisis *          
# participants affected / at risk     2/349 (0.57%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     1     0     0     0  
Hypotension *          
# participants affected / at risk     2/349 (0.57%)     4/342 (1.17%)     1/67 (1.49%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     5     1     0     0  
Hypovolaemic shock *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Intermittent claudication *          
# participants affected / at risk     2/349 (0.57%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     1     0     0     0  
Ischaemic limb pain *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Jugular vein thrombosis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Orthostatic hypotension *          
# participants affected / at risk     2/349 (0.57%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     0     0     0     0  
Peripheral arterial occlusive disease *          
# participants affected / at risk     2/349 (0.57%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     3     1     0     0     0  
Peripheral embolism *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Peripheral ischaemia *          
# participants affected / at risk     2/349 (0.57%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     2     0     0     0     0  
Peripheral vascular disorder *          
# participants affected / at risk     8/349 (2.29%)     4/342 (1.17%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     8     5     0     0     0  
Steal syndrome *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Subclavian vein thrombosis *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Thrombophlebitis *          
# participants affected / at risk     1/349 (0.29%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     1     0     0     0  
Vascular insufficiency *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Vasculitis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
Venous occlusion *          
# participants affected / at risk     1/349 (0.29%)     0/342 (0.00%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     1     0     0     0     0  
Venous thrombosis *          
# participants affected / at risk     0/349 (0.00%)     1/342 (0.29%)     0/67 (0.00%)     0/51 (0.00%)     0/109 (0.00%)  
# events     0     1     0     0     0  
* Events were collected by non-systematic assessment




  Other Adverse Events


  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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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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Publications automatically indexed to this study:

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