CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 409 enrolled
Drug / intervention
Pacing system implant with the CapsureFix MRI pacing lead model 5086device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01522755
NCT01522755N/ACompleted

Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Medtronic Cardiac Rhythm and Heart Failure·observational·Posted Feb 1, 2012·Updated Jul 2, 2025

In Brief

An observational study evaluating Pacing system implant with the CapsureFix MRI pacing lead model 5086 for Bradyarrhythmia. Completed, enrolled 409 participants across 1 site.

Detailed Summary

Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances. These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history). Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086. This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBradyarrhythmia
CountriesFrance
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2012
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.4 years ago

Interventions

Pacing system implant with the CapsureFix MRI pacing lead model 5086device

Pacing system implant with the CapsureFix MRI pacing lead model 5086