French Attitude Registry in Case of ICD Lead Replacement (FRAGILE)
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|ClinicalTrials.gov Identifier: NCT01829269|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : August 7, 2019
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.
|Condition or disease|
|Defibrillator Explantation of Probe|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||559 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||French Attitude Registry in Case of ICD Lead Replacement|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Patients with a defibrillator
The study population is that of patients with a defibrillator to have a change of probe.
- Explanted probes [ Time Frame: 2 years ]Percentage of explanted probes among implanted ones
- Complications of explantation [ Time Frame: 2 years ]Percentage of events during and after explantation of probe
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829269
|Clinique Ambroise Paré|
|Neuilly Sur Seine, France, 92200|