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Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00187278
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Atrioventricular Block
Ventricular Dysfunction
Interventions Device: Biventricular Pacing
Device: RV Pacing
Enrollment 1833
Recruitment Details Patients were enrolled between May 2003 and September 2007.
Pre-assignment Details

1834 patients have been scheduled for randomization, while 1833 have been randomized to RV Pacing or Biventricular group.

One patient could not be randomized due to organizational reasons.

Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Period Title: Overall Study
Started 918 915
Completed 908 902
Not Completed 10 13
Reason Not Completed
Protocol Violation             10             13
Arm/Group Title RV Pacing Biventricular Pacing Total
Hide Arm/Group Description

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Total of all reporting groups
Overall Number of Baseline Participants 908 902 1810
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 908 participants 902 participants 1810 participants
73.3  (9.0) 73.8  (9.0) 73.5  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
Female
296
  32.6%
278
  30.8%
574
  31.7%
Male
612
  67.4%
624
  69.2%
1236
  68.3%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 908 participants 902 participants 1810 participants
27.5  (4.7) 27.4  (4.3) 27.4  (4.5)
Ventricular pacing at 1 month  
Mean (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 908 participants 902 participants 1810 participants
86.4
(48 to 88)
90.2
(67 to 93)
88.3
(56 to 91)
Underlying cardiac diseases  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
All 572 571 1143
Ischaemic heart disease 274 274 548
Hypertensive heart disease 281 262 543
Dlated cardiomyopathy 43 51 94
Valvulopathy 170 165 335
Prior MI 162 141 308
Cardiovascular risk factor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
Hypertension 696 666 1362
Diabetes mellitus 255 251 506
[1]
Measure Description: Some participants experienced more than one cardiovascular risk factor.
Left ventricular ejection fraction (LVEF)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 908 participants 902 participants 1810 participants
55.5  (12.4) 55.3  (12.1) 55.4  (12.2)
Left Ventricular Ejection Fraction (LVEF) range  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
LVEF ≤ 35% 74 78 152
35% < LVEF ≤ 50% 221 198 419
LVEF > 50% 613 626 1239
QRS duration  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 908 participants 902 participants 1810 participants
118.8  (30.3) 118.1  (30.8) 118.4  (30.5)
QRS range  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
QRS ≤ 120ms 571 571 1142
120ms < QRS ≤ 150ms 190 176 366
QRS > 150ms 147 155 302
Atrial arrhythmias  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
Atrial arrhythmias 225 225 450
None 683 677 1360
Left bundle branch block (LBBB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
LBBB 166 150 316
None 742 752 1494
Scheduled for ICD  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
Scheduled for ICD 22 26 48
Not scheduled for ICD 886 976 1762
Indications for device implantation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 908 participants 902 participants 1810 participants
Persistent bradycardia 538 540 1078
Intermittent bradycardia 368 362 730
Unknown 2 0 2
1.Primary Outcome
Title Total Mortality
Hide Description Number of deaths observed
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 908 902
Measure Type: Count of Participants
Unit of Measure: Participants
307
  33.8%
305
  33.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Pacing, Biventricular Pacing
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3492
Comments adjusted p
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.926
Confidence Interval (2-Sided) 95%
0.789 to 1.0088
Estimation Comments [Not Specified]
2.Primary Outcome
Title Death or Heart Failure Hospitalization
Hide Description Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 908 902
Measure Type: Count of Participants
Unit of Measure: Participants
346
  38.1%
363
  40.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Pacing, Biventricular Pacing
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0882
Comments adjusted p
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.878
Confidence Interval (2-Sided) 95%
0.756 to 1.020
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Death Due to Cardiovascular Causes
Hide Description Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 908 902
Measure Type: Count of Participants
Unit of Measure: Participants
106
  11.7%
107
  11.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Pacing, Biventricular Pacing
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8215
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.74 to 1.27
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Hide Description [Not Specified]
Time Frame 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all enrolled patients who completed the 6-minute walk test both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module.
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 672 675
Mean (Standard Deviation)
Unit of Measure: meters
371.3  (128.8) 371.2  (129.1)
5.Secondary Outcome
Title Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Hide Description

Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months

MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.

Time Frame 12 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module.
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 724 715
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.0  (15.4) 15.3  (15.5)
6.Secondary Outcome
Title Incidence of Hospitalizations for Deterioration of Heart Failure
Hide Description [Not Specified]
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: hospitalization per patient year
0.043 0.037
7.Secondary Outcome
Title Incidence of Hospitalizations for Cardiovascular Events
Hide Description [Not Specified]
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: hospitalizations per patient year
0.162 0.161
8.Secondary Outcome
Title Incidence of Hospitalizations for Any Reason
Hide Description [Not Specified]
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: Hospitalization per patient year
0.392 0.432
9.Secondary Outcome
Title Cardiac Structure and Function
Hide Description [Not Specified]
Time Frame 12 & 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data related to cardiac structure and function can not be presented as the data was not collected and analysis provided by the core lab.
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Successful Implantation of the Left Ventricular Lead
Hide Description [Not Specified]
Time Frame Implantation
Hide Outcome Measure Data
Hide Analysis Population Description
There was an attempt of left ventricular lead implantation only for subjects from Biventricular Pacing group.
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 0 883
Measure Type: Number
Unit of Measure: participants
760
11.Secondary Outcome
Title Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits)
Hide Description Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits.
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 908 902
Measure Type: Number
Unit of Measure: participants
91 76
12.Secondary Outcome
Title Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Hide Description [Not Specified]
Time Frame 24 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 614 592
Mean (Standard Deviation)
Unit of Measure: meters
369.3  (127.2) 376.5  (132.0)
13.Secondary Outcome
Title Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Hide Description

Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months.

MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.

Time Frame 24 months post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 24-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module.
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 662 675
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.5  (17.6) 17.3  (16.6)
14.Secondary Outcome
Title Duration of Hospitalizations for Deterioration of Heart Failure
Hide Description [Not Specified]
Time Frame Study Duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: days per patient year
0.40 0.39
15.Secondary Outcome
Title Duration of Hospitalizations for Cardiovascular Events
Hide Description [Not Specified]
Time Frame Study Duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: Days per patient year
1.52 1.50
16.Secondary Outcome
Title Duration of Hospitalizations for Any Reason
Hide Description [Not Specified]
Time Frame Study duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:

Standard Pacemaker implant

RV Pacing: Standard Pacemaker implant

Biventricular Pacemaker implant

Biventricular Pacing: Biventricular Pacemaker implant

Overall Number of Participants Analyzed 899 888
Measure Type: Number
Unit of Measure: days per patient year
3.72 4.14
17.Secondary Outcome
Title Adverse Events Related to Left Ventricular Lead
Hide Description Only serious adverse events related to the left ventricular lead are included.
Time Frame Study Duration (5.7 years mean follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description:
Standard Pacemaker implant
Biventricular Pacemaker implant
Overall Number of Participants Analyzed 908 902
Measure Type: Number
Unit of Measure: participants
1 38
Time Frame Study duration (5.7 years mean follow-up)
Adverse Event Reporting Description The sponsor assessed all events except the death cases without further information, duplicate events and uncomplicated device replacement due to end of life. 5628 events were reviewed and assessed by the sponsor. Subjects may experience more than one adverse event.
 
Arm/Group Title RV Pacing Biventricular Pacing
Hide Arm/Group Description Standard Pacemaker implant Biventricular Pacemaker implant
All-Cause Mortality
RV Pacing Biventricular Pacing
Affected / at Risk (%) Affected / at Risk (%)
Total   307/908 (33.81%)      305/902 (33.81%)    
Hide Serious Adverse Events
RV Pacing Biventricular Pacing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   641/908 (70.59%)      698/902 (77.38%)    
Blood and lymphatic system disorders     
Anemia  1  14/908 (1.54%)  19 14/902 (1.55%)  16
Epistaxis  1 [1]  3/908 (0.33%)  3 2/902 (0.22%)  2
Haemoptysis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Hematochezia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Hypercalcemia  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Hyperkalemia  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Hyponatremia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Thromboemboli  1  2/908 (0.22%)  2 6/902 (0.67%)  6
Cardiac disorders     
AV Fistula  1  1/908 (0.11%)  1 3/902 (0.33%)  5
Acute Coronary Syndrome  1  5/908 (0.55%)  7 1/902 (0.11%)  1
Angina  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Arrhythmia  1  48/908 (5.29%)  56 54/902 (5.99%)  75
Bradycardia  1  3/908 (0.33%)  3 0/902 (0.00%)  0
Cardiac arrest  1  2/908 (0.22%)  2 2/902 (0.22%)  3
Cardiomyopathy  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Chest Pain  1  50/908 (5.51%)  68 48/902 (5.32%)  63
Dyspnea  1  46/908 (5.07%)  71 60/902 (6.65%)  74
Endocarditis  1  2/908 (0.22%)  2 5/902 (0.55%)  7
Exacerbation of heart failure  1  132/908 (14.54%)  179 103/902 (11.42%)  144
Hypertension  1  13/908 (1.43%)  16 18/902 (2.00%)  20
Hypertrophic obstructive cardiomyopathy  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Hypotension  1  5/908 (0.55%)  5 5/902 (0.55%)  5
Mitral Regurgitation  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Myocardial infarction  1  29/908 (3.19%)  34 26/902 (2.88%)  26
Palpitations  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Rise in threshold and exit block  1  12/908 (1.32%)  12 22/902 (2.44%)  24
Shortness of Breath  1  4/908 (0.44%)  4 3/902 (0.33%)  3
Valve damage  1  26/908 (2.86%)  36 18/902 (2.00%)  19
Congenital, familial and genetic disorders     
Lowry Wood Syndrome  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/908 (0.00%)  0 4/902 (0.44%)  4
Endocrine disorders     
Diabetes  1  10/908 (1.10%)  13 12/902 (1.33%)  12
Glycemia  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Hyperglycemia  1  2/908 (0.22%)  2 4/902 (0.44%)  4
Hypoglycemia  1  3/908 (0.33%)  5 5/902 (0.55%)  6
Eye disorders     
Cataract  1  2/908 (0.22%)  3 1/902 (0.11%)  1
Galucoma  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Macular Degeneration  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Gastrointestinal disorders     
Cholangitis  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Constipation  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Diverticulitis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Gastrointestinal Bleeding  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Gastrointestinal disease  1  0/908 (0.00%)  0 3/902 (0.33%)  3
Gastrointestinal disorder  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Nausea  1  3/908 (0.33%)  3 2/902 (0.22%)  2
Pancreatitis  1  4/908 (0.44%)  6 3/902 (0.33%)  4
Ulcer  1  2/908 (0.22%)  2 4/902 (0.44%)  6
Antral gastritis  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Appendicitis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Bowel obstruction  1  1/908 (0.11%)  2 0/902 (0.00%)  0
Diarrhea  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Gastroenteritis  1  4/908 (0.44%)  4 2/902 (0.22%)  2
Hernia  1  16/908 (1.76%)  16 8/902 (0.89%)  8
Intestinal Obstruction  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Rectal Bleeding  1  1/908 (0.11%)  1 0/902 (0.00%)  0
General disorders     
Dizziness  1  15/908 (1.65%)  17 16/902 (1.77%)  18
Drug Toxicity  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Dysphagia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Dysphonia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Esophagitis  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Fever  1  11/908 (1.21%)  11 12/902 (1.33%)  13
Hospitalization for non-cardiac diseases  1  74/908 (8.15%)  86 87/902 (9.65%)  110
Hydrocephalus  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Influenza  1  5/908 (0.55%)  5 1/902 (0.11%)  1
Lyme Disease  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Malaise  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Pain  1  47/908 (5.18%)  57 55/902 (6.10%)  65
Shingles  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Stenosis  1  22/908 (2.42%)  22 17/902 (1.88%)  20
Syncope  1  22/908 (2.42%)  25 17/902 (1.88%)  18
Weakness  1  6/908 (0.66%)  6 4/902 (0.44%)  5
Worsening of General Patient's Condition  1  39/908 (4.30%)  47 59/902 (6.54%)  65
Hepatobiliary disorders     
Cirrhosis  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Gallbladder disease  1  2/908 (0.22%)  2 2/902 (0.22%)  2
Gallstones  1  1/908 (0.11%)  1 8/902 (0.89%)  11
Jaundice  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Immune system disorders     
Allergy  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Infections and infestations     
Infection  1  58/908 (6.39%)  76 87/902 (9.65%)  118
Sepsis  1  6/908 (0.66%)  6 7/902 (0.78%)  10
Septic shock  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Injury, poisoning and procedural complications     
Abdominal adhesions post surgery  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Accidental injury  1  2/908 (0.22%)  2 8/902 (0.89%)  8
Acute hemorrhage/bleeding  1  26/908 (2.86%)  27 35/902 (3.88%)  39
Air emboli  1  9/908 (0.99%)  11 10/902 (1.11%)  10
Amputation  1  5/908 (0.55%)  7 8/902 (0.89%)  9
Cardiac or venous perforation  1  6/908 (0.66%)  6 9/902 (1.00%)  9
Cardiac/coronary sinus dissection  1  2/908 (0.22%)  2 3/902 (0.33%)  3
Coronary sinus or cardiac vein thrombosis  1  5/908 (0.55%)  5 6/902 (0.67%)  6
Erosion  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Excessive bleeding  1  6/908 (0.66%)  6 2/902 (0.22%)  2
Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)  1  1/908 (0.11%)  1 12/902 (1.33%)  12
Fall  1  33/908 (3.63%)  34 39/902 (4.32%)  42
Hematoma/seroma formation  1  14/908 (1.54%)  22 19/902 (2.11%)  19
Laceration  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Medication Error  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Pericardial effusion  1  1/908 (0.11%)  1 8/902 (0.89%)  10
Pericarditis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Pleural Effusion  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Pneumothorax  1  3/908 (0.33%)  3 5/902 (0.55%)  5
Metabolism and nutrition disorders     
Dehydration  1  2/908 (0.22%)  2 3/902 (0.33%)  3
Musculoskeletal and connective tissue disorders     
Arthritis  1  2/908 (0.22%)  2 2/902 (0.22%)  2
Bone fracture  1  24/908 (2.64%)  28 32/902 (3.55%)  37
Coxarthrosis  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Gout  1  2/908 (0.22%)  2 1/902 (0.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenomatous polyps  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Cancer  1  24/908 (2.64%)  26 32/902 (3.55%)  36
Local tissue reaction; formation of fibrotic tissue; cyst formation  1  15/908 (1.65%)  20 16/902 (1.77%)  16
Tumor  1  33/908 (3.63%)  40 35/902 (3.88%)  48
Nervous system disorders     
Concussion  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Delirium  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Depression  1  4/908 (0.44%)  4 4/902 (0.44%)  4
Dimentia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Epilepsy  1  4/908 (0.44%)  4 4/902 (0.44%)  5
Orthostatic intolerance  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Parkinson's disease  1  4/908 (0.44%)  4 2/902 (0.22%)  2
Radicular syndrome  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Sclerosis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Sleep Apnea  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Product Issues     
Inappropriate mode switch  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Inappropriate shocks  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Lead Fracture  1  2/908 (0.22%)  2 1/902 (0.11%)  1
Lead migration, dislodgment or poor lead placement  1  31/908 (3.41%)  37 36/902 (3.99%)  39
Loss of Capture  1  3/908 (0.33%)  3 6/902 (0.67%)  6
Mechanical malfunction of the pacing lead  1  2/908 (0.22%)  3 1/902 (0.11%)  1
Oversensing  1  3/908 (0.33%)  4 2/902 (0.22%)  2
Pacemaker Mediated Tachycardia  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Pacing Lead Impedance Out of Range  1  3/908 (0.33%)  3 3/902 (0.33%)  4
Pulse Generator Reset  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Undersensing  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Psychiatric disorders     
Altered Mental Status  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Renal and urinary disorders     
Cardiac or venous perforation  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Hematuria  1  1/908 (0.11%)  2 0/902 (0.00%)  0
Kidney Stones  1  1/908 (0.11%)  2 0/902 (0.00%)  0
Kidney disease  1  8/908 (0.88%)  8 7/902 (0.78%)  9
Macrohematuria  1  1/908 (0.11%)  2 0/902 (0.00%)  0
Nephrocalcinosis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Renal Disease  1  11/908 (1.21%)  12 20/902 (2.22%)  20
Renal failure  1  16/908 (1.76%)  17 21/902 (2.33%)  22
Ureteral Obstruction  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Urinary Retention  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Urinary Track Disease  1  6/908 (0.66%)  6 5/902 (0.55%)  8
Respiratory, thoracic and mediastinal disorders     
Bronchitis  1  5/908 (0.55%)  5 5/902 (0.55%)  5
Chronic obstructive pulmonary disease  1  10/908 (1.10%)  18 17/902 (1.88%)  21
Pleurisy  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Pneumonia  1  52/908 (5.73%)  58 36/902 (3.99%)  41
Pulmonary edema  1  14/908 (1.54%)  15 16/902 (1.77%)  24
Respiratory Disease  1  11/908 (1.21%)  13 11/902 (1.22%)  15
Skin and subcutaneous tissue disorders     
Abscess  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Erythema  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Surgical and medical procedures     
Colposcopy  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Coronary artery bypass surgery  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Endoscopic Retrograde Cholangiopancreatography  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Iron Infusion  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Percutaneous Coronary Intervention  1  27/908 (2.97%)  32 19/902 (2.11%)  27
Planned Lead Revision  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Planned Pulse Generator Replacement  1  191/908 (21.04%)  201 306/902 (33.92%)  335
Pulse Generator Pocket Revision  1  1/908 (0.11%)  1 2/902 (0.22%)  3
Surgery  1  77/908 (8.48%)  89 80/902 (8.87%)  101
Vascular disorders     
Aneurysm  1  7/908 (0.77%)  10 4/902 (0.44%)  4
Cerebrovascular Accident  1  5/908 (0.55%)  5 9/902 (1.00%)  10
Coronary artery disease  1  5/908 (0.55%)  5 4/902 (0.44%)  5
Deep vein thrombosis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Fluid accumulation  1  26/908 (2.86%)  32 35/902 (3.88%)  39
Lim Ischemia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Peripheral Arterial Occlusive Disease  1  3/908 (0.33%)  3 2/902 (0.22%)  2
Peripheral artery disease  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Stroke  1  21/908 (2.31%)  27 26/902 (2.88%)  29
Transient Ischemic Attack  1  16/908 (1.76%)  18 26/902 (2.88%)  28
Venous occlusion  1  2/908 (0.22%)  3 3/902 (0.33%)  3
1
Term from vocabulary, ISO 14155:2011
Indicates events were collected by systematic assessment
[1]
device pocket revision, lead dysfunction.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RV Pacing Biventricular Pacing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   451/908 (49.67%)      507/902 (56.21%)    
Blood and lymphatic system disorders     
Anemia  1  5/908 (0.55%)  5 4/902 (0.44%)  4
Bicytopenia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Epistaxis  1  1/908 (0.11%)  2 3/902 (0.33%)  3
Hematochezia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Hypereosinophilia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Hyperkalemia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Thromboemboli  1  3/908 (0.33%)  3 5/902 (0.55%)  5
Cardiac disorders     
Acute Coronary Syndrome  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Arrhythmia  1  96/908 (10.57%)  119 107/902 (11.86%)  135
Arteritis  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Bigeminy  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Cardiac arrest  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Chest Pain  1  24/908 (2.64%)  29 31/902 (3.44%)  43
Dyspnea  1  38/908 (4.19%)  47 47/902 (5.21%)  55
Exacerbation of heart failure  1  23/908 (2.53%)  24 23/902 (2.55%)  23
Heart block  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Hypertension  1  8/908 (0.88%)  9 13/902 (1.44%)  15
Hypotension  1  7/908 (0.77%)  9 8/902 (0.89%)  8
Mitral Regurgitation  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Myocardial infarction  1  9/908 (0.99%)  9 4/902 (0.44%)  4
Palpitations  1  7/908 (0.77%)  8 4/902 (0.44%)  6
Percutaneous Coronary Intervention  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Rise in threshold and exit block  1  12/908 (1.32%)  12 27/902 (2.99%)  31
Shortness of Breath  1  11/908 (1.21%)  11 7/902 (0.78%)  9
Valve damage  1  10/908 (1.10%)  14 4/902 (0.44%)  4
Ear and labyrinth disorders     
Tinnitus  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Vertigo  1  3/908 (0.33%)  3 2/902 (0.22%)  3
Endocrine disorders     
Diabetes  1  12/908 (1.32%)  12 13/902 (1.44%)  14
Hyperlipidemia  1  2/908 (0.22%)  2 1/902 (0.11%)  1
Hypoglycemia  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Toxic multinodular goitre  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Eye disorders     
Cataract  1  7/908 (0.77%)  7 5/902 (0.55%)  7
Galucoma  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Macular Degeneration  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Gastrointestinal disorders     
Constipation  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Diverticulitis  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Nausea  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Pancreatitis  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Ulcer  1  3/908 (0.33%)  3 0/902 (0.00%)  0
Abdominal pain  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Antral gastritis  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Diarrhea  1  2/908 (0.22%)  3 1/902 (0.11%)  1
Gastroenteritis  1  3/908 (0.33%)  4 2/902 (0.22%)  2
Hernia  1  6/908 (0.66%)  6 5/902 (0.55%)  6
Ulcerative colitis  1  1/908 (0.11%)  1 2/902 (0.22%)  2
General disorders     
Cold  1  3/908 (0.33%)  3 1/902 (0.11%)  1
Dizziness  1  19/908 (2.09%)  19 13/902 (1.44%)  13
Drug Toxicity  1  1/908 (0.11%)  2 3/902 (0.33%)  3
Dysphonia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Esophagitis  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Fever  1  4/908 (0.44%)  4 5/902 (0.55%)  6
Genital Prolapse  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Hospitalization for non-cardiac diseases  1  24/908 (2.64%)  26 18/902 (2.00%)  21
Influenza  1  2/908 (0.22%)  2 1/902 (0.11%)  1
Pain  1  61/908 (6.72%)  87 53/902 (5.88%)  64
Prolapse  1  0/908 (0.00%)  0 1/902 (0.11%)  2
Shingles  1  3/908 (0.33%)  3 1/902 (0.11%)  1
Short Loss of Consciousness  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Stenosis  1  4/908 (0.44%)  4 4/902 (0.44%)  4
Syncope  1  12/908 (1.32%)  14 12/902 (1.33%)  13
Tremor  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Weakness  1  3/908 (0.33%)  3 1/902 (0.11%)  1
Worsening of General Patient's Condition  1  51/908 (5.62%)  61 50/902 (5.54%)  54
Hepatobiliary disorders     
Dysfibrinogenemia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Gallbladder disease  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Gallstones  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Immune system disorders     
Allergy  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Infections and infestations     
Infection  1  27/908 (2.97%)  33 53/902 (5.88%)  65
Sepsis  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Injury, poisoning and procedural complications     
Accidental injury  1  4/908 (0.44%)  4 10/902 (1.11%)  10
Acute hemorrhage/bleeding  1  8/908 (0.88%)  9 15/902 (1.66%)  16
Air emboli  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Amputation  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Asystole during implant  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Coronary Sinus Cannulation Failure  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Cardiac or venous perforation  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Cardiac tamponade  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Cardiac/coronary sinus dissection  1  0/908 (0.00%)  0 8/902 (0.89%)  8
Coronary sinus or cardiac vein thrombosis  1  0/908 (0.00%)  0 8/902 (0.89%)  8
Erosion  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Excessive bleeding  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Extracardiac stimulation (phrenic nerve, diaphragm, chest wall)  1  14/908 (1.54%)  14 77/902 (8.54%)  95
Fall  1  25/908 (2.75%)  29 31/902 (3.44%)  34
Hematoma/seroma formation  1  13/908 (1.43%)  13 29/902 (3.22%)  31
Inverted connection of RV and LV Leads  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Laceration  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Pericardial effusion  1  2/908 (0.22%)  2 1/902 (0.11%)  1
Pneumothorax  1  6/908 (0.66%)  6 8/902 (0.89%)  8
Steal Syndrome  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Trauma  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  5/908 (0.55%)  5 1/902 (0.11%)  1
Bone fracture  1  15/908 (1.65%)  15 9/902 (1.00%)  9
Carpal tunnel syndrome  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Coxarthrosis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Gonarthrosis  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Gout  1  2/908 (0.22%)  2 6/902 (0.67%)  7
Hypertonia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Tendinitis  1  3/908 (0.33%)  3 1/902 (0.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  11/908 (1.21%)  11 11/902 (1.22%)  11
Local tissue reaction; formation of fibrotic tissue; cyst formation  1  8/908 (0.88%)  8 3/902 (0.33%)  3
Tumor  1  12/908 (1.32%)  14 15/902 (1.66%)  15
Nervous system disorders     
Depression  1  3/908 (0.33%)  3 2/902 (0.22%)  2
Epilepsy  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Facial nerve paralysis  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Parethesia  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Parkinson's disease  1  3/908 (0.33%)  4 5/902 (0.55%)  5
Sleep Apnea  1  1/908 (0.11%)  2 0/902 (0.00%)  0
Product Issues     
Decreased CRT pacing  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Inability to defibrillate  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Inappropriate mode switch  1  1/908 (0.11%)  2 1/902 (0.11%)  1
Inappropriate shocks  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Lead migration, dislodgment or poor lead placement  1  26/908 (2.86%)  27 42/902 (4.66%)  42
Loss of Capture  1  6/908 (0.66%)  6 8/902 (0.89%)  9
Mechanical malfunction of the pacing lead  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Oversensing  1  6/908 (0.66%)  7 6/902 (0.67%)  6
Pacemaker Mediated Tachycardia  1  3/908 (0.33%)  3 1/902 (0.11%)  1
Pacing Lead Impedance Out of Range  1  2/908 (0.22%)  2 4/902 (0.44%)  5
Pulse Generator Reset  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Undersensing  1  5/908 (0.55%)  5 4/902 (0.44%)  4
Renal and urinary disorders     
Elevated uric acid  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Hematuria  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Kidney disease  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Prostatism  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Renal Disease  1  4/908 (0.44%)  4 6/902 (0.67%)  6
Renal failure  1  2/908 (0.22%)  2 5/902 (0.55%)  5
Urinary Retention  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Urinary Track Disease  1  5/908 (0.55%)  5 4/902 (0.44%)  7
Respiratory, thoracic and mediastinal disorders     
Bronchitis  1  6/908 (0.66%)  6 4/902 (0.44%)  4
Chronic obstructive pulmonary disease  1  5/908 (0.55%)  6 12/902 (1.33%)  12
Nocturnal desaturation  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Pleurisy  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Pneumonia  1  8/908 (0.88%)  9 8/902 (0.89%)  8
Pulmonary edema  1  5/908 (0.55%)  7 1/902 (0.11%)  1
Respiratory Disease  1  3/908 (0.33%)  3 4/902 (0.44%)  5
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Mastitis  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Rosacea on Face  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Seborrheic keratosis  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Surgical and medical procedures     
Colposcopy  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Medication Titration  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Percutaneous Coronary Intervention  1  7/908 (0.77%)  7 9/902 (1.00%)  9
Planned Lead Revision  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Planned Pulse Generator Replacement  1  9/908 (0.99%)  9 15/902 (1.66%)  15
Pulse Generator Pocket Revision  1  0/908 (0.00%)  0 2/902 (0.22%)  2
Surgery  1  52/908 (5.73%)  58 52/902 (5.76%)  64
Vascular disorders     
Aneurysm  1  1/908 (0.11%)  1 1/902 (0.11%)  1
Cerebrovascular Accident  1  3/908 (0.33%)  3 2/902 (0.22%)  3
Coronary artery disease  1  1/908 (0.11%)  1 3/902 (0.33%)  3
Deep vein thrombosis  1  1/908 (0.11%)  1 2/902 (0.22%)  2
Fluid accumulation  1  23/908 (2.53%)  24 24/902 (2.66%)  25
Hemorrhoids  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Lim Ischemia  1  0/908 (0.00%)  0 1/902 (0.11%)  1
Peripheral Arterial Occlusive Disease  1  2/908 (0.22%)  2 0/902 (0.00%)  0
Stroke  1  3/908 (0.33%)  3 2/902 (0.22%)  2
Transient Ischemic Attack  1  11/908 (1.21%)  14 12/902 (1.33%)  12
Varicose Veins  1  1/908 (0.11%)  1 0/902 (0.00%)  0
Venous occlusion  1  1/908 (0.11%)  1 1/902 (0.11%)  1
1
Term from vocabulary, ISO 14155:2011
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Pascale Ducloux, Clinical Manager
Organization: St Jude Medical
Phone: +3227746709
EMail: pducloux@sjm.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00187278    
Other Study ID Numbers: CR03006HF
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: January 27, 2016
Results First Posted: January 25, 2021
Last Update Posted: January 25, 2021