Trial Outcomes & Findings for BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes (NCT NCT01062126)
NCT ID: NCT01062126
Last Updated: 2020-10-14
Results Overview
Complication rate and 95% confidence interval at 1-year post-implant
Recruitment status
COMPLETED
Target enrollment
3389 participants
Primary outcome timeframe
12 months
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
All Subjects Enrolled in the Study
Patients implanted with an SJM Accent SR/DR, Accent SR/DR RF, Anthem CRT-P, Anthem CRT-P RF, or newer SJM pacemaker device
|
|---|---|
|
Overall Study
STARTED
|
3389
|
|
Overall Study
COMPLETED
|
2856
|
|
Overall Study
NOT COMPLETED
|
533
|
Reasons for withdrawal
| Measure |
All Subjects Enrolled in the Study
Patients implanted with an SJM Accent SR/DR, Accent SR/DR RF, Anthem CRT-P, Anthem CRT-P RF, or newer SJM pacemaker device
|
|---|---|
|
Overall Study
Death
|
209
|
|
Overall Study
All Withdrawals
|
324
|
Baseline Characteristics
BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Baseline characteristics by cohort
| Measure |
All Subjects Enrolled in the Study
n=3389 Participants
All subjects that were enrolled in the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
559 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2830 Participants
n=99 Participants
|
|
Age, Continuous
|
74.8 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1546 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1843 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
185 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3175 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3389 participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
Sinus Node Dysfunction
|
2427 Participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
AV Node Block
|
754 Participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
Syncope
|
220 Participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
Pacemaker Replacement
|
329 Participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
PAVE
|
55 Participants
n=99 Participants
|
|
Primary Indication for Pacemaker Implant
Others
|
20 Participants
n=99 Participants
|
|
Cardiovascular History
Coronary Artery Disease
|
1361 Participants
n=99 Participants
|
|
Cardiovascular History
Angina
|
156 Participants
n=99 Participants
|
|
Cardiovascular History
Myocardial Infarction
|
204 Participants
n=99 Participants
|
|
Cardiovascular History
Heart Failure
|
25 Participants
n=99 Participants
|
|
Cardiovascular History
Hypertension
|
2668 Participants
n=99 Participants
|
|
Ejection Fraction
|
56.8 % of blood leaving heart at contraction
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Other Medical History
Pulmonary disease
|
335 Participants
n=99 Participants
|
|
Other Medical History
Hepatic/Renal disease
|
306 Participants
n=99 Participants
|
|
Other Medical History
Diabetes
|
869 Participants
n=99 Participants
|
|
Other Medical History
Peripheral vascular disease
|
240 Participants
n=99 Participants
|
|
Medications
ACE Inhibitors/ARBs
|
1659 Participants
n=99 Participants
|
|
Medications
Aldosterone inhibitors
|
64 Participants
n=99 Participants
|
|
Medications
Anti-coagulants
|
1064 Participants
n=99 Participants
|
|
Medications
Antiarrhythmics - Class I
|
103 Participants
n=99 Participants
|
|
Medications
Antiarrhythmics - Class III
|
356 Participants
n=99 Participants
|
|
Medications
Antiplatelet
|
1833 Participants
n=99 Participants
|
|
Medications
Beta Blockers
|
1653 Participants
n=99 Participants
|
|
Medications
Calcium channel blockers
|
936 Participants
n=99 Participants
|
|
Medications
Cardiac glycosides
|
239 Participants
n=99 Participants
|
|
Medications
Diuretics
|
1172 Participants
n=99 Participants
|
|
Medications
Nitrates
|
360 Participants
n=99 Participants
|
|
Medications
Other cardiac
|
351 Participants
n=99 Participants
|
|
Medications
Positive Ionotropics
|
11 Participants
n=99 Participants
|
|
Medications
Statins
|
150 Participants
n=99 Participants
|
|
Systolic BP
|
130.1 mm Hg
STANDARD_DEVIATION 19.6 • n=99 Participants
|
|
Diastolic BP
|
72.2 mm Hg
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Heart Rate
|
69.4 beats per min (bpm)
STANDARD_DEVIATION 12.1 • n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All subjects enrolled in the study.
Complication rate and 95% confidence interval at 1-year post-implant
Outcome measures
| Measure |
All Subjects Enrolled in the Study
n=3389 Participants
All subjects that were enrolled in the study.
|
|---|---|
|
Complication Rate at 1-year Post-implant
|
1.12 percentage of enrolled subjects
Interval 0.8 to 1.5
|
Adverse Events
All Subjects Enrolled in the Study
Serious events: 38 serious events
Other events: 17 other events
Deaths: 209 deaths
Serious adverse events
| Measure |
All Subjects Enrolled in the Study
n=3389 participants at risk
All subjects that were enrolled in the study.
|
|---|---|
|
Product Issues
Lead dislodgement or migration
|
0.41%
14/3389 • Number of events 15 • Adverse events reported during the 1-year study.
|
|
Infections and infestations
Infection
|
0.18%
6/3389 • Number of events 6 • Adverse events reported during the 1-year study.
|
|
Product Issues
Elevated pacing thresholds
|
0.09%
3/3389 • Number of events 3 • Adverse events reported during the 1-year study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Gastrointestinal disorders
Bleeding/Hematoma
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Product Issues
Diaphragmatic/Phrenic Nerve Stimulation
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Dehisence
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Product Issues
Lead Malfunction
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Product Issues
Lead fracture
|
0.12%
4/3389 • Number of events 4 • Adverse events reported during the 1-year study.
|
|
Product Issues
Loss of capture
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Mid-sternal pain at the location of RA and RV leads
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Open wound at PG incision site
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Product Issues
Oversensing
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Pericardial effusion
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Pericardial tamponade
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Pocket Revision- not Healing
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
|
Injury, poisoning and procedural complications
Set Screw not secured at Implant
|
0.03%
1/3389 • Number of events 1 • Adverse events reported during the 1-year study.
|
Other adverse events
| Measure |
All Subjects Enrolled in the Study
n=3389 participants at risk
All subjects that were enrolled in the study.
|
|---|---|
|
Product Issues
Elevated pacing thresholds
|
0.18%
6/3389 • Number of events 6 • Adverse events reported during the 1-year study.
|
|
Product Issues
Oversensing
|
0.09%
3/3389 • Number of events 3 • Adverse events reported during the 1-year study.
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Product Issues
Inappropriate device interaction
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Product Issues
Loss of capture
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Vascular disorders
Syncope
|
0.06%
2/3389 • Number of events 2 • Adverse events reported during the 1-year study.
|
|
Vascular disorders
Hematoma
|
0.09%
3/3389 • Number of events 3 • Adverse events reported during the 1-year study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60