Trial Outcomes & Findings for Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086 (NCT NCT01522755)
NCT ID: NCT01522755
Last Updated: 2025-07-02
Results Overview
Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Recruitment status
COMPLETED
Target enrollment
409 participants
Primary outcome timeframe
at implant
Results posted on
2025-07-02
Participant Flow
Recruitment period: 31 January 2010 - 24 January 2013. 32 implanting centers and 41 implanters participated in the study.
Participant milestones
| Measure |
Patients Implanted With the CapsureFix MRI Pacing Lead
Patients implanted with the CapsureFix MRI pacing lead model 5086
|
|---|---|
|
Overall Study
STARTED
|
409
|
|
Overall Study
COMPLETED
|
409
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Baseline characteristics by cohort
| Measure |
Patients Implanted With the CapsureFix MRI Pacing Lead
n=409 Participants
Patients implanted with the CapsureFix MRI pacing lead model 5086
|
|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
409 participants
n=5 Participants
|
|
Pacing indication
Sinoatrial block
|
40 participants
n=5 Participants
|
|
Pacing indication
Sinus bradycardia
|
51 participants
n=5 Participants
|
|
Pacing indication
1st degree AV block
|
21 participants
n=5 Participants
|
|
Pacing indication
2nd degree AV block Wenckebach
|
19 participants
n=5 Participants
|
|
Pacing indication
2nd degree AV block Mobitz 2
|
62 participants
n=5 Participants
|
|
Pacing indication
Permanent 3rd degree AV block
|
59 participants
n=5 Participants
|
|
Pacing indication
Paroxysmal 3rd degree AV block
|
57 participants
n=5 Participants
|
|
Pacing indication
Sinus node disease
|
82 participants
n=5 Participants
|
|
Pacing indication
Other
|
18 participants
n=5 Participants
|
|
Atrial arrhythmia history
Patients with atrial arrhythmia history
|
126 participants
n=5 Participants
|
|
Atrial arrhythmia history
Patients with no atrial arrythmia history
|
283 participants
n=5 Participants
|
|
Ventricular arrhythmia history
Patients with ventricular arrhytmia history
|
14 participants
n=5 Participants
|
|
Ventricular arrhythmia history
Patients with no ventricular arrhythmia history
|
395 participants
n=5 Participants
|
|
cardiac disease history
Patients with cardiac disease history
|
95 participants
n=5 Participants
|
|
cardiac disease history
Patient with no cardiac disease history
|
314 participants
n=5 Participants
|
|
coronary disease history
Patients with coronary disease history
|
59 participants
n=5 Participants
|
|
coronary disease history
Patients with no coronary disease history
|
350 participants
n=5 Participants
|
|
Myocardial infarction history
Patients with myocardial infarction history
|
28 participants
n=5 Participants
|
|
Myocardial infarction history
Patients with no myocardial infarction history
|
381 participants
n=5 Participants
|
|
Stroke history
Patients with stroke history
|
37 participants
n=5 Participants
|
|
Stroke history
Patients with no stroke history
|
372 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at implantEase of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Outcome measures
| Measure |
Implanting Physicians
n=41 Participants
Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
|
|---|---|
|
Ease of Implant
maneuverability for the atrium
|
6.9 score on a scale
Standard Deviation 1.2
|
|
Ease of Implant
maneuverability for the ventricle
|
6.3 score on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 3 monthsLead stability of the Capsure Fix as measured by number of dislodgments
Outcome measures
| Measure |
Implanting Physicians
n=409 Participants
Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
|
|---|---|
|
Lead Stability
|
10 dislodgements
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 409 patients have been consecutively enrolled in 32 sites.
Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086
Outcome measures
| Measure |
Implanting Physicians
n=409 Participants
Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
|
|---|---|
|
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Pacing threshold Implant (RA)
|
0.9 Volt
Standard Deviation 0.5
|
|
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Pacing threshold Post implant (RA)
|
0.6 Volt
Standard Deviation 0.3
|
|
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Pacing threshold Implant (RV)
|
0.7 Volt
Standard Deviation 0.4
|
|
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
Pacing threshold Post implant (RV)
|
0.6 Volt
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 3 monthsChange of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Outcome measures
| Measure |
Implanting Physicians
n=409 Participants
Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
|
|---|---|
|
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Sensing Implant (RA)
|
3.2 mV
Standard Deviation 1.9
|
|
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Sensing Post Implant (RA)
|
3.2 mV
Standard Deviation 2.2
|
|
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Sensing Implant (RV)
|
10.9 mV
Standard Deviation 5.2
|
|
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
Sensing Post Implant (RV)
|
9.5 mV
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: 3 monthsChange of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Outcome measures
| Measure |
Implanting Physicians
n=409 Participants
Questionnaires on ease of implant, maneuverability of the catheter, and other variables were taken during this study.
|
|---|---|
|
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Impedance Implant RA
|
704 Ohm
Standard Deviation 242
|
|
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Impedance Post Implant RA
|
547 Ohm
Standard Deviation 175
|
|
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Impedance Implant RV
|
896 Ohm
Standard Deviation 286
|
|
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
Impendance Post Implant RV
|
635 Ohm
Standard Deviation 200
|
Adverse Events
Patients Implanted With the CapsureFix MRI Pacing Lead
Serious events: 16 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Implanted With the CapsureFix MRI Pacing Lead
n=409 participants at risk
Patients implanted with the CapsureFix MRI pacing lead model 5086
|
|---|---|
|
Cardiac disorders
Lead displacement
|
2.4%
10/409 • Number of events 10 • From the informed consent signature to the end of the study.
|
|
Cardiac disorders
hemopericardium
|
0.49%
2/409 • Number of events 2 • From the informed consent signature to the end of the study.
|
|
Cardiac disorders
Hospitalization
|
0.24%
1/409 • Number of events 1 • From the informed consent signature to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Permanent disability
|
0.24%
1/409 • Number of events 1 • From the informed consent signature to the end of the study.
|
|
Cardiac disorders
Hospitalization due to electrical issue
|
0.49%
2/409 • Number of events 2 • From the informed consent signature to the end of the study.
|
Other adverse events
| Measure |
Patients Implanted With the CapsureFix MRI Pacing Lead
n=409 participants at risk
Patients implanted with the CapsureFix MRI pacing lead model 5086
|
|---|---|
|
Cardiac disorders
electrical abnormal parameters
|
2.0%
8/409 • Number of events 8 • From the informed consent signature to the end of the study.
|
|
Cardiac disorders
lead displacement
|
0.49%
2/409 • Number of events 2 • From the informed consent signature to the end of the study.
|
|
Cardiac disorders
pneumothorax
|
0.24%
1/409 • Number of events 1 • From the informed consent signature to the end of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place