CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 559 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01829269
NCT01829269N/ACompleted

French Attitude Registry in Case of ICD Lead Replacement

French Cardiology Society·observational·Posted Apr 11, 2013·Updated Aug 7, 2019

In Brief

An observational study for Defibrillator and Explantation of Probe. Completed, enrolled 559 participants across 1 site.

Detailed Summary

The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced. There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe. The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%. Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued. Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2013
Enrollment StartApr 1, 2013
Primary CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 13.2 years ago