Trial Outcomes & Findings for Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P) (NCT NCT02488239)
NCT ID: NCT02488239
Last Updated: 2019-09-20
Results Overview
Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
Recruitment status
COMPLETED
Target enrollment
64 participants
Primary outcome timeframe
3 months post-implant
Results posted on
2019-09-20
Participant Flow
The first subject was enrolled on 11 May 2015 and the study was completed on 22 March 2017, which corresponds to the last visit of the last subject. A total of 64 subjects across 8 centers were enrolled in Finland and Germany.
Participant milestones
| Measure |
Actively Enrolled Patients
Patients actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Actively Enrolled Patients
Patients actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Consent ineligible
|
1
|
|
Overall Study
Did not undergo implant procedure
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Actively Enrolled Patients
n=61 Participants
Patients actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 10.06 • n=61 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=61 Participants
|
|
Region of Enrollment
Finland
|
15 participants
n=61 Participants
|
|
Region of Enrollment
Germany
|
46 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 3 months post-implantPopulation: Out of 61 actively enrolled subjects (3 subjects were not implanted with the study device), 55 patients continued the study for at least 3 months: 6 subjects were excluded from analysis because either they died or withdrew before 3 months analysis, or because no 3 months data was available.
Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
Outcome measures
| Measure |
Actively Enrolled Patients
n=55 Participants
Subjects actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Percentage of Participants Without CRT-P Device Related Complications
|
100 % of participants
Interval 94.7 to 100.0
|
PRIMARY outcome
Timeframe: 3 months post-implantPopulation: 61 actively enrolled subjects were included in the analysis. 3 subjects did not receive the study device.
Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.
Outcome measures
| Measure |
Actively Enrolled Patients
n=61 Participants
Subjects actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
LV Pacing Threshold
|
1.65 Volt
Interval 1.38 to 1.93
|
Adverse Events
Actively Enrolled Patients
Serious events: 20 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Actively Enrolled Patients
n=61 participants at risk
Patients actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
6.6%
4/61 • Number of events 4 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Other SVT
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Renal and urinary disorders
Renal
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Myocardial Infarction
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Vascular disorders
Coronary Artery Disease
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Pulmonary edema - heart failure
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Heart failure symptoms - unspecified
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Chest pain - ischemic
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Dyspnea
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Hypertension
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Mitral regurgitation
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Cerebrovascular accident
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Ventricular tachycardia
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
LV - elevated threshold
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
LV - extracardiac stimulation
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Surgical and medical procedures
Procedure - coronary venous dissection
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
RA - dislogement - elevated threshold
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
RV - dislodgement - elevated threshold
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
Other adverse events
| Measure |
Actively Enrolled Patients
n=61 participants at risk
Patients actively enrolled and implanted with a 3-lead CRT-P system.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
6.6%
4/61 • Number of events 6 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Device Deficiency
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Dyspnea - Heart failure
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Elevated threshold - RA
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Extracardiac stimulation - LV
|
4.9%
3/61 • Number of events 4 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Surgical and medical procedures
Hematoma - Pocket (<= 30 days post-implant)
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Inability to maintain telemetry
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Infection (> 30 days post-implant)
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Other - Lead - Procedure
|
3.3%
2/61 • Number of events 2 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Other- Patient condition - Cardiovascular
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
General disorders
Other- Patient condition - Non- cardiovascular
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Pacemaker-mediated tachycardia (PMT)
|
16.4%
10/61 • Number of events 16 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Surgical and medical procedures
Pneumothorax - Procedure
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Surgical and medical procedures
Post-surgical wound discomfort
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Premature atrial contractions (PAC)
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Premature ventricular contractions (PVC)
|
9.8%
6/61 • Number of events 11 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Cardiac disorders
Syncope
|
1.6%
1/61 • Number of events 1 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
|
Product Issues
Undersensing - RA
|
4.9%
3/61 • Number of events 3 • Adverse events are collected from enrollment throughout study completion (last subject last visit)
All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.
- Publication restrictions are in place
Restriction type: OTHER