Trial Outcomes & Findings for INGEVITY™ Observational Trial (NCT NCT02166606)
NCT ID: NCT02166606
Last Updated: 2021-03-30
Results Overview
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.
Recruitment status
COMPLETED
Target enrollment
1184 participants
Primary outcome timeframe
91 calendar days post-implant
Results posted on
2021-03-30
Participant Flow
Enrollment in the study began on 02 April 2014. The enrollment completion for the GENTLE study was communicated to the participating sites on 26 February 2016. However, additional subjects were enrolled after this date and the last subject signed consent on 08 March 2016. The last subject last visit was on 07 June 2016.
1184 subjects signed the informed consent (IC). 4 subjects signed the IC only after the end of enrollment. 1180 subjects signed IC before the end of enrollment and are considered 'actively enrolled'. 1174 subjects met all eligibility criteria and were thus considered 'consent eligible' and were considered for the baseline.
Participant milestones
| Measure |
Pacemaker/Lead Implant
All enrolled subjects received an ImageReady Magnet Resonant (MR) Conditional Pacing System according to standard-of-care. No study-specific interventions were performed in the registry. The treatment assignment was based on an "all-comers" consecutive basis.
|
|---|---|
|
Overall Study
STARTED
|
1184
|
|
Overall Study
Actively Enrolled
|
1180
|
|
Overall Study
Consent Eligible
|
1174
|
|
Overall Study
COMPLETED
|
1106
|
|
Overall Study
NOT COMPLETED
|
78
|
Reasons for withdrawal
| Measure |
Pacemaker/Lead Implant
All enrolled subjects received an ImageReady Magnet Resonant (MR) Conditional Pacing System according to standard-of-care. No study-specific interventions were performed in the registry. The treatment assignment was based on an "all-comers" consecutive basis.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
31
|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Lost to Follow-up
|
30
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Device upgrade
|
1
|
|
Overall Study
Enrolled after End of Enrollment
|
4
|
Baseline Characteristics
INGEVITY™ Observational Trial
Baseline characteristics by cohort
| Measure |
Pacemaker/Lead Implant
n=1174 Participants
All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an "all-comers" consecutive basis.
ImageReady MR Conditional Pacing System Implant: Implant according to standard-of-care.
No study-specific interventions in that registry.
|
|---|---|
|
Age, Continuous
|
74.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
413 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
761 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
170 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
38 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
84 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
208 participants
n=5 Participants
|
|
Region of Enrollment
France
|
372 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
121 participants
n=5 Participants
|
|
Primary Brady Indication
None
|
0 participants
n=5 Participants
|
|
Primary Brady Indication
Sinus bradycardia
|
92 participants
n=5 Participants
|
|
Primary Brady Indication
Sinus node dysfunction
|
249 participants
n=5 Participants
|
|
Primary Brady Indication
Sinus arrest
|
51 participants
n=5 Participants
|
|
Primary Brady Indication
Chronotropic incompetence
|
17 participants
n=5 Participants
|
|
Primary Brady Indication
1st degree AV block
|
33 participants
n=5 Participants
|
|
Primary Brady Indication
2nd degree AV block
|
247 participants
n=5 Participants
|
|
Primary Brady Indication
3rd degree AV block
|
293 participants
n=5 Participants
|
|
Primary Brady Indication
Other
|
192 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 91 calendar days post-implantLead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.
Outcome measures
| Measure |
Pacemaker/Lead Implant
n=1174 Participants
All enrolled subjects successfully implanted with a complete ImageReady™ System.
|
|---|---|
|
Percentage of Leads Free From Complication
|
97.3 percentage of leads complication-free
Interval 96.2 to 98.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 365 calendar days post implantThe percentage of subjects who underwent an MRI scan through 12 months post-implant.
Outcome measures
| Measure |
Pacemaker/Lead Implant
n=1174 Participants
All enrolled subjects successfully implanted with a complete ImageReady™ System.
|
|---|---|
|
MRI Procedures Through 12 Months Post-Implant
|
2.3 Percentage of subjects with MRI Scan
|
Adverse Events
Pacemaker/Lead Implant
Serious events: 197 serious events
Other events: 0 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Pacemaker/Lead Implant
n=1174 participants at risk
All enrolled subjects successfully implanted with a complete ImageReady™ System.
|
|---|---|
|
Gastrointestinal disorders
Non-Cardiovascular/General
|
0.26%
3/1174 • 1 year
|
|
General disorders
Non-Cardiovascular/General
|
0.09%
1/1174 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Non-Cardiovascular/General
|
0.85%
10/1174 • 1 year
|
|
Injury, poisoning and procedural complications
Non-Cardiovascular/General
|
0.60%
7/1174 • 1 year
|
|
Renal and urinary disorders
Non-Cardiovascular/General
|
0.43%
5/1174 • 1 year
|
|
Nervous system disorders
Non-Cardiovascular/General
|
0.09%
1/1174 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Non-Cardiovascular/General
|
0.43%
5/1174 • 1 year
|
|
Endocrine disorders
Non-Cardiovascular/General
|
0.34%
4/1174 • 1 year
|
|
Infections and infestations
Non-Cardiovascular/General
|
0.26%
3/1174 • 1 year
|
|
Blood and lymphatic system disorders
Non-Cardiovascular/General
|
0.17%
2/1174 • 1 year
|
|
Psychiatric disorders
Non-Cardiovascular/General
|
0.09%
1/1174 • 1 year
|
|
Cardiac disorders
Atrial Tachyarrhythmias
|
0.51%
6/1174 • 1 year
|
|
Cardiac disorders
Related to Ischemia
|
0.26%
3/1174 • 1 year
|
|
General disorders
Symptoms (Non-Heart Failure Related)
|
0.09%
1/1174 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Symptoms (Non-Heart Failure Related)
|
0.17%
2/1174 • 1 year
|
|
Cardiac disorders
Symptoms (Non-Heart Failure Related)
|
0.09%
1/1174 • 1 year
|
|
Cardiac disorders
Related to Heart Failure
|
0.09%
1/1174 • 1 year
|
|
Vascular disorders
Related to Blood Pressure
|
0.09%
1/1174 • 1 year
|
|
Vascular disorders
Related to Vasculature
|
0.43%
5/1174 • 1 year
|
|
Cardiac disorders
Ventricular Tachyarrythmias
|
0.09%
1/1174 • 1 year
|
|
Blood and lymphatic system disorders
Thromboembolic Events
|
0.17%
2/1174 • 1 year
|
|
Infections and infestations
Other (Unrelated to Procedure/Device)
|
0.09%
1/1174 • 1 year
|
|
Product Issues
Right Atrium - Brady
|
0.09%
1/1174 • 1 year
|
|
Product Issues
Right Ventricle - Brady
|
0.09%
1/1174 • 1 year
|
|
Injury, poisoning and procedural complications
Procedure
|
0.09%
1/1174 • 1 year
|
|
Injury, poisoning and procedural complications
PG System - Procedure
|
0.09%
1/1174 • 1 year
|
|
Injury, poisoning and procedural complications
PG system - Procedure
|
0.09%
1/1174 • 1 year
|
|
Product Issues
Device Deficiency
|
0.26%
3/1174 • 1 year
|
|
Product Issues
Atrial Tachyarrhythmias
|
0.17%
2/1174 • 1 year
|
|
Infections and infestations
PG System - Subject
|
0.09%
1/1174 • 1 year
|
|
Product Issues
PG System - Therapy
|
0.09%
1/1174 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Consultant (PI) acknowledges and agrees that (i) Consultant shall not publish any data, report, white papers or other materials arising out of the Services performed pursuant to this Agreement without the prior written consent of Boston Scientific, and (ii) any such publication shall not include Boston Scientific Confidential Information except prior written consent of Boston Scientific.
- Publication restrictions are in place
Restriction type: OTHER