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French Attitude Registry in Case of ICD Lead Replacement

French Attitude Registry in Case of ICD Lead Replacement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01829269
Acronym
FRAGILE
Enrollment
559
Registered
2013-04-11
Start date
2013-04-30
Completion date
2019-05-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillator, Explantation of Probe

Brief 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.

Interventions

None listed

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Explanted probes2 yearsPercentage of explanted probes among implanted ones

Secondary

MeasureTime frameDescription
Complications of explantation2 yearsPercentage of events during and after explantation of probe

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026