French Attitude Registry in Case of ICD Lead Replacement (FRAGILE)

French Cardiology Society

Status: Completed

Conditions: Explantation of Probe; Defibrillator

Study type: Observational

Funder types: Other

Identifiers

NCT01829269

12 759

Details and patient eligibility

About

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.

Enrollment: 559 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed.
• Patient who agreed to participate in the study
• Patients aged 18 years and over

No Exclusion Criteria

Trial design

559 participants in 1 patient group

Patients with a defibrillator

Description:

The study population is that of patients with a defibrillator to have a change of probe.