Trial Outcomes & Findings for Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II (NCT NCT02577887)
NCT ID: NCT02577887
Last Updated: 2020-03-09
Results Overview
The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
Recruitment status
COMPLETED
Target enrollment
2101 participants
Primary outcome timeframe
1 year
Results posted on
2020-03-09
Participant Flow
Participant milestones
| Measure |
All Consented Patients
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Overall Study
STARTED
|
2101
|
|
Overall Study
6 Month Follow-up
|
1938
|
|
Overall Study
COMPLETED
|
1803
|
|
Overall Study
NOT COMPLETED
|
298
|
Reasons for withdrawal
| Measure |
All Consented Patients
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Overall Study
Death
|
93
|
|
Overall Study
Protocol Violation
|
125
|
|
Overall Study
Withdrawal by Subject
|
80
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Consented Patients
n=2101 Participants
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Age, Continuous
|
74.5 years
STANDARD_DEVIATION 10.6 • n=2101 Participants
|
|
Sex: Female, Male
Female
|
896 Participants
n=2101 Participants
|
|
Sex: Female, Male
Male
|
1205 Participants
n=2101 Participants
|
|
Region of Enrollment
Japan
|
234 Participants
n=2101 Participants
|
|
Region of Enrollment
Italy
|
178 Participants
n=2101 Participants
|
|
Region of Enrollment
France
|
241 Participants
n=2101 Participants
|
|
Region of Enrollment
Germany
|
236 Participants
n=2101 Participants
|
|
Region of Enrollment
Austria
|
96 Participants
n=2101 Participants
|
|
Region of Enrollment
Belgium
|
64 Participants
n=2101 Participants
|
|
Region of Enrollment
China
|
48 Participants
n=2101 Participants
|
|
Region of Enrollment
Estonia
|
183 Participants
n=2101 Participants
|
|
Region of Enrollment
Finland
|
92 Participants
n=2101 Participants
|
|
Region of Enrollment
Hong Kong
|
10 Participants
n=2101 Participants
|
|
Region of Enrollment
India
|
56 Participants
n=2101 Participants
|
|
Region of Enrollment
Lithuania
|
46 Participants
n=2101 Participants
|
|
Region of Enrollment
Netherlands
|
131 Participants
n=2101 Participants
|
|
Region of Enrollment
Portugal
|
102 Participants
n=2101 Participants
|
|
Region of Enrollment
South Korea
|
155 Participants
n=2101 Participants
|
|
Region of Enrollment
Spain
|
157 Participants
n=2101 Participants
|
|
Region of Enrollment
United Kingdom
|
72 Participants
n=2101 Participants
|
|
Primary Indication
Sinus Node Dysfunction
|
868 Participants
n=2101 Participants
|
|
Primary Indication
AV Node Block
|
1026 Participants
n=2101 Participants
|
|
Primary Indication
Syncope
|
189 Participants
n=2101 Participants
|
|
Primary Indication
Prevention/Termination of Tachyarrhythmias by Paci
|
16 Participants
n=2101 Participants
|
|
Primary Indication
Pacemaker replacement
|
2 Participants
n=2101 Participants
|
|
Cardiovascular History
Angina
|
62 Participants
n=2101 Participants
|
|
Cardiovascular History
Cardiomyopathy
|
438 Participants
n=2101 Participants
|
|
Cardiovascular History
Coronary Artery Disease
|
452 Participants
n=2101 Participants
|
|
Cardiovascular History
Heart Failure
|
4 Participants
n=2101 Participants
|
|
Cardiovascular History
Hypertension
|
1371 Participants
n=2101 Participants
|
|
Cardiovascular History
Myocardial infarction
|
182 Participants
n=2101 Participants
|
|
Medication
ACE Inhibitors/ ARBs
|
1124 Participants
n=2101 Participants
|
|
Medication
Aldosterone Inhibitors
|
85 Participants
n=2101 Participants
|
|
Medication
Anti-Coagulants
|
679 Participants
n=2101 Participants
|
|
Medication
Antiarrhythmics- Class I
|
82 Participants
n=2101 Participants
|
|
Medication
Antiarrhythmics- Class III
|
98 Participants
n=2101 Participants
|
|
Medication
Antiplatelet
|
665 Participants
n=2101 Participants
|
|
Medication
Beta Blockers
|
711 Participants
n=2101 Participants
|
|
Medication
Calcium Channel Blockers
|
612 Participants
n=2101 Participants
|
|
Medication
Cardiac Glycosides
|
46 Participants
n=2101 Participants
|
|
Medication
Diuretics
|
730 Participants
n=2101 Participants
|
|
Medication
Nitrates
|
109 Participants
n=2101 Participants
|
|
Medication
Other Cardiac
|
96 Participants
n=2101 Participants
|
|
Medication
Positive Inotropics
|
3 Participants
n=2101 Participants
|
|
Medication
Statins
|
154 Participants
n=2101 Participants
|
|
Blood Pressure (mm Hg)
Diastolic Blood Pressure
|
74.8 mm Hg
STANDARD_DEVIATION 12.2 • n=2101 Participants
|
|
Blood Pressure (mm Hg)
Systolic Blood Pressure
|
138.3 mm Hg
STANDARD_DEVIATION 21.9 • n=2101 Participants
|
|
Ejection Fraction (%)
|
59.6 % of blood leaving heart at contraction
STANDARD_DEVIATION 9.4 • n=2101 Participants
|
|
Heart Rate (bpm)
|
64.2 bpm
STANDARD_DEVIATION 16.4 • n=2101 Participants
|
|
Other Medical History
Diabetes
|
509 Participants
n=2101 Participants
|
|
Other Medical History
Heaptic/Renal disease
|
253 Participants
n=2101 Participants
|
|
Other Medical History
Peripheral vascular disease
|
90 Participants
n=2101 Participants
|
|
Other Medical History
Pulmonary disease
|
89 Participants
n=2101 Participants
|
|
Other Medical History
Smoking
|
634 Participants
n=2101 Participants
|
|
Other Medical History
Stroke
|
216 Participants
n=2101 Participants
|
|
Cardiovascular Interventions
Ablation
|
3 Participants
n=2101 Participants
|
|
Cardiovascular Interventions
Coronary Artery Bypass Grafting (CABG)
|
113 Participants
n=2101 Participants
|
|
Cardiovascular Interventions
Perc Coronary Intervention (PCI )/ Atherectomy
|
251 Participants
n=2101 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All subjects.
The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
Outcome measures
| Measure |
All Consented Patients
n=2101 Participants
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Percentage of Participants With Complications in the General Pacemaker Population
|
3.33 percentage of subjects
Interval 2.6 to 4.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All study participants that completed that 12-month visit and had the feature enabled for the duration of the study. Subjects that had a change in the status of the feature (e.g. ON to OFF) are not included in the count shown here.
Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.
Outcome measures
| Measure |
All Consented Patients
n=1803 Participants
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Ventricular Intrinsic Preference
|
732 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
AF Suppression
|
10 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: High RV Rate
|
1738 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: High V Rate during AT/AF
|
1439 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: AT/AF
|
1432 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: Exceeded AT/AF Burden
|
1433 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: % V Pace
|
1280 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: Atrial Impedance Out of Range
|
34 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Trigger Alert: Ventricular Impedance Out of Range
|
37 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Remote Monitoring
|
198 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Atrial Capture Confirm
|
245 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Right Ventricular Auto Capture
|
678 Participants
|
|
Number of Subjects Programmed With Advanced Pacemaker Features
Atrial Pace during PMT
|
1412 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients that completed the 12-month follow-up visit.
At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.
Outcome measures
| Measure |
All Consented Patients
n=1803 Participants
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
Number of subjects with PMT
|
563 Participants
|
|
Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
Number of subjects with AT/AF
|
427 Participants
|
|
Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
Number of subjects with VT/VF
|
861 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All study participants
The total number of scans performed by country
Outcome measures
| Measure |
All Consented Patients
n=2101 Participants
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Number of MRI Scans by Country
France
|
10 scans
|
|
Number of MRI Scans by Country
Belgium
|
7 scans
|
|
Number of MRI Scans by Country
Austria
|
6 scans
|
|
Number of MRI Scans by Country
Netherland
|
5 scans
|
|
Number of MRI Scans by Country
Spain
|
4 scans
|
|
Number of MRI Scans by Country
South Korea
|
4 scans
|
|
Number of MRI Scans by Country
Estonia
|
34 scans
|
|
Number of MRI Scans by Country
Italy
|
14 scans
|
|
Number of MRI Scans by Country
Germany
|
13 scans
|
|
Number of MRI Scans by Country
Japan
|
13 scans
|
|
Number of MRI Scans by Country
Finland
|
2 scans
|
|
Number of MRI Scans by Country
UK
|
2 scans
|
|
Number of MRI Scans by Country
Portugal
|
2 scans
|
Adverse Events
All Consented Patients
Serious events: 70 serious events
Other events: 19 other events
Deaths: 94 deaths
Serious adverse events
| Measure |
All Consented Patients
n=2101 participants at risk
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Product Issues
Loss of Normal Desired Pacing and/or Sensing due to Lead Displacement
|
1.2%
25/2101 • Number of events 26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.43%
9/2101 • Number of events 9 • 1 year
|
|
General disorders
Unknown Death
|
0.29%
6/2101 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac Perforation
|
0.19%
4/2101 • Number of events 4 • 1 year
|
|
Vascular disorders
Hematoma
|
0.19%
4/2101 • Number of events 4 • 1 year
|
|
Product Issues
Lead Malfunction
|
0.14%
3/2101 • Number of events 3 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac Tamponade
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Cardiac disorders
Endocarditis
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Product Issues
Pacemaker Mediated Tachycardia
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Nervous system disorders
TIA
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Device Migration
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Immune system disorders
Inflammatory Allergic Reaction
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Lead Misplacement
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Product Issues
Loss of Normal Device Function due to Battery Failure or Component Malfunction
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis associated with Dressler's Syndrome
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Pocket Erosion
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Investigations
Reduction of LVEF due to RV Pacing
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Nervous system disorders
Stroke
|
0.05%
1/2101 • Number of events 1 • 1 year
|
|
Product Issues
Threshold Elevation
|
0.05%
1/2101 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
All Consented Patients
n=2101 participants at risk
Patients implanted with Accent MRI, Assurity MRI, Endurity MRI or other newer SJM pacemakers, with a standard indication for implant.
|
|---|---|
|
Vascular disorders
Hematoma
|
0.24%
5/2101 • Number of events 5 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.14%
3/2101 • Number of events 3 • 1 year
|
|
Product Issues
Lead Noise
|
0.14%
3/2101 • Number of events 3 • 1 year
|
|
Product Issues
Threshold Elevation
|
0.14%
3/2101 • Number of events 3 • 1 year
|
|
Product Issues
Extracardiac Stimulation
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Product Issues
Pacemaker Mediated Tachycardia
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
General disorders
Pain at IPG Site
|
0.10%
2/2101 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
2/2101 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place