Trial Outcomes & Findings for Longitudinal Surveillance Study of the 4-SITE Lead/Header System (NCT NCT01596595)
NCT ID: NCT01596595
Last Updated: 2021-03-19
Results Overview
The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
Recruitment status
COMPLETED
Target enrollment
1820 participants
Primary outcome timeframe
5 years
Results posted on
2021-03-19
Participant Flow
Participant milestones
| Measure |
RELIANCE 4-SITE
There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study.
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|---|---|
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Overall Study
STARTED
|
1779
|
|
Overall Study
COMPLETED
|
814
|
|
Overall Study
NOT COMPLETED
|
965
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Baseline characteristics by cohort
| Measure |
RELIANCE 4-SITE
n=1790 Participants
Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.
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|---|---|
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Age, Continuous
|
64.0 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
481 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1309 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1345 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
249 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
106 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
39 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
19 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Hawaiian
|
2 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participant selections
n=93 Participants
|
|
Race/Ethnicity, Customized
Missing data
|
8 Participant selections
n=93 Participants
|
|
Region of Enrollment
Canada
|
107 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
1681 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThe 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
Outcome measures
| Measure |
RELIANCE 4-SITE
n=1779 Participants
There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study. These 41 subjects are not included in the endpoint analysis. The endpoint was analyzed using intent to treat analysis.
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|---|---|
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Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
|
98.9 Percentage of participants
Interval 98.5 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
Adverse Events
RELIANCE 4-SITE
Serious events: 1017 serious events
Other events: 980 other events
Deaths: 327 deaths
Serious adverse events
| Measure |
RELIANCE 4-SITE
n=1820 participants at risk
All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820).
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|---|---|
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Product Issues
Other - PG System
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate Tachy Therapy - SVT
|
1.6%
30/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate Tachy Therapy - Other
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Early ERI - Premature Declaration
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Pacemaker Mediated Tachycardia (PMT)
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Erosion
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
Infection (> 30 days post implant)
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma- Pocket (>30 days post implant)
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Migration
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post -Surgical infection (≤ 30 days post implant)
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - Respiratory
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Chest pain
|
0.27%
5/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma - pocket (≤ 30 days post-implant)
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Thromboembolic events
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Procedure - PG System - Other
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to Capture - RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Multiple signs- RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - RA
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Other Lead Related
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Oversensing - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Capture - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Extracardiac Stimulation - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Insulation Breach - RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Myocardial Perforation post implant- RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Low Out of Range Impedance - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to capture - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Elevated threshold - RV
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Extracardiac stimulation - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Multiple signs - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - RV
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Capture - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Extracardiac Stimulation - LV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Conductor Coil Fracture - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Insulation Breach - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to Capture - LV
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Elevated threshold - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Extracardiac stimulation - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Multiple signs - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - LV
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy - SVT
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hemothorax
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Myocardial perforation without tamponade
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Myocardial perforation with tamponade
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Procedure - Lead - Other
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
3rd Degree AV Block
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.27%
5/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pulseless Electrical Activity (PEA)
|
0.71%
13/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
1.6%
29/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
4.0%
72/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Torsades de Pointes
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
4.6%
83/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
0.82%
15/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
0.55%
10/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Syncope - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Dizziness - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Chest Pain - Heart Failure
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
5.9%
108/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Peripheral edema - Heart Failure
|
0.55%
10/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pulmonary Edema - Heart Failure
|
0.82%
15/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Fatigue - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Renal Failure/Insufficiency - Heart Failure
|
0.66%
12/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Dehydration - Heart Failure
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Gastrointestinal - Heart Failure
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Hypotension - Heart Failure
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Weight Gain - Heart Failure
|
0.88%
16/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Heart Failure Symptoms - Unspecified
|
7.8%
142/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
10.2%
185/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Hypertension - Heart Failure
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Heart Failure Patient Condition - Cardiovascular - OTHER
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Multi-system Failure - Heart Failure
|
0.71%
13/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
2.0%
37/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
0.60%
11/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Cardiogenic Shock
|
1.1%
20/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Cardiac Arrest
|
2.3%
41/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Myocardial Infarction
|
3.4%
62/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Peripheral Vascular Disease
|
2.1%
38/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Intermittent Claudication
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Aortic Stenosis
|
0.49%
9/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Aortic Regurgitation
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Mitral Stenosis
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Mitral Regurgitation
|
0.49%
9/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Syncope
|
2.0%
37/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Dizziness
|
1.3%
23/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Chest Pain - Ischemic
|
1.0%
19/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Chest Pain - Other
|
3.7%
68/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.66%
12/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Palpitations
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Fatigue/Weakness
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Multiple Symptoms
|
0.27%
5/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Patient Condition - Cardiovascular - OTHER
|
3.4%
62/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
1.4%
25/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (CVA)
|
2.8%
51/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis (DVT)
|
0.66%
12/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Pulmonary Embolism (PE)
|
0.88%
16/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Distal thromboemboli
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pericardial effusion - unrelated procedure/device
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pericarditis - unrelated procedure/device
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hematoma - unrelated procedure/device
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hemorrhage - unrelated procedure/device
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Patient Condition - Non-Cardiovascular - OTHER
|
2.6%
47/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Death
|
2.1%
38/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
System Infection
|
4.2%
76/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
Fever and/or Virus
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Physical Trauma
|
4.2%
76/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Abnormal Laboratory Values
|
2.0%
36/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Blood and lymphatic system disorders
Hematological
|
2.1%
39/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Nervous system disorders
Neurological
|
3.0%
54/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
10.3%
188/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
10.1%
183/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Renal and urinary disorders
Genitourinary
|
2.7%
50/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Renal and urinary disorders
Renal
|
5.9%
108/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.6%
83/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Psychiatric disorders
Psychological
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
2.1%
39/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
2.0%
37/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Endocrine disorders
Endocrine
|
1.5%
27/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
3.7%
68/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Multi-System Failure
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
Other adverse events
| Measure |
RELIANCE 4-SITE
n=1820 participants at risk
All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820).
|
|---|---|
|
Product Issues
Oversensing - RA
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Capture - RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Other - PG System
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Oversensing - RV 1120 - Undersensing - RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - RV
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - LV
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Extracardiac Stimulation - LV
|
1.6%
29/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate Tachy Therapy - SVT
|
2.4%
43/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate Tachy Therapy - Other
|
0.60%
11/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Early ERI - Premature declaration
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Pacemaker Mediated Tachycardia (PMT)
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
Infection (> 30 days post implant)
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma- Pocket (>30 days post implant)
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Seroma - Pocket (>30 days post implant)
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Migration
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
4.5%
82/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post -Surgical infection (≤ 30 days post implant)
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - General
|
0.55%
10/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - Respiratory
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - Bradycardia
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - Hypotension
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Inadvertent VT/VF
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Chest pain
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Physical trauma
|
0.27%
5/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma - pocket (≤ 30 days post-implant)
|
4.0%
72/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Seroma - Pocket (≤ 30 days post implant)
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Thromboembolic events
|
0.49%
9/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Procedure - PG System - Other
|
0.49%
9/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Undersensing - RA 2032 - Unable to Capture - RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - RA
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Extracardiac Stimulation - RA
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Conductor Coil Fracture - RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
High Out of Range Impedance - RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Multiple signs- RA
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - RA
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Other Lead Related
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Oversensing - RV
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Undersensing - RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Capture - RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
|
0.66%
12/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Extracardiac Stimulation - RV
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Myocardial Perforation post implant- RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Low Out of Range Impedance - RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to capture - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Elevated threshold - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Oversensing- RV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Multiple signs - RV
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - RV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Capture - LV
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Low Out of Range Impedance - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to Capture - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Dislodgement - No reported signs - LV
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Unable to Convert
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy - SVT
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy - Noise
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Puncture Site hematoma
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Pleural effusion
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Chronotropic Incompetence
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
1.3%
24/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
4.0%
73/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Torsades de Pointes
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
3.0%
54/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
6.1%
111/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
1.5%
28/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
1.4%
25/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.93%
17/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Syncope - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Dizziness - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Chest Pain - Heart Failure
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
2.7%
49/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Peripheral edema - Heart Failure
|
2.1%
39/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pulmonary Edema - Heart Failure
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Fatigue - Heart Failure
|
0.22%
4/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Renal Failure/Insufficiency - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Gastrointestinal - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Hypotension - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Weight Gain - Heart Failure
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Heart Failure Symptoms - Unspecified
|
2.0%
37/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
4.1%
75/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Hypertension - Heart Failure
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Heart Failure Patient Condition - Cardiovascular - OTHER
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
3.6%
65/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
2.3%
42/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Myocardial Infarction
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Peripheral Vascular Disease
|
1.5%
27/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Intermittent Claudication
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Aortic Stenosis
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Aortic Regurgitation
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Mitral Regurgitation
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Syncope
|
1.3%
23/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Dizziness
|
3.6%
65/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Chest Pain - Ischemic
|
0.77%
14/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Chest Pain - Other
|
4.6%
83/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
41/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Palpitations
|
0.88%
16/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Fatigue/Weakness
|
2.1%
39/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Patient Condition - Cardiovascular - OTHER
|
1.8%
32/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.27%
5/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (CVA)
|
0.16%
3/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis (DVT)
|
0.66%
12/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Pulmonary Embolism (PE)
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Distal thromboemboli
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.44%
8/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pericardial effusion - unrelated procedure/device
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Cardiac disorders
Pericarditis - unrelated procedure/device
|
0.11%
2/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Vascular disorders
Hematoma - unrelated procedure/device
|
0.33%
6/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Patient Condition - Non-Cardiovascular - OTHER
|
6.0%
109/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
System Infection
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Infections and infestations
Fever and/or Virus
|
0.05%
1/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Physical Trauma
|
5.3%
97/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Abnormal Laboratory Values
|
5.2%
95/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Blood and lymphatic system disorders
Hematological
|
1.9%
34/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Nervous system disorders
Neurological
|
3.7%
67/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
9.1%
166/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
6.8%
123/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Renal and urinary disorders
Genitourinary
|
5.2%
95/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Renal and urinary disorders
Renal
|
4.1%
74/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
9.1%
165/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Psychiatric disorders
Psychological
|
1.6%
29/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
5.4%
99/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
10.2%
185/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Endocrine disorders
Endocrine
|
3.2%
58/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Immune system disorders
Immune
|
0.38%
7/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.9%
34/1820 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
|
Additional Information
Paji Vitoff, Manager, Clinical Trials
Boston Scientific
Phone: 651-582-5415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60