French Attitude Registry in Case of ICD Lead Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

NCT00614718

Death, Sudden, Cardiac Ventricular Fibrillation

COMPLETED

Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

NCT04206371

Implantable Cardioverter-Defibrillators

COMPLETED NA

Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

NCT05123885

Infarction, Myocardial

COMPLETED

Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead

NCT00180297

Ventricular Tachycardia Ventricular Fibrillation

COMPLETED NA

Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

NCT00598026

Defibrillators, Implantable Telemedicine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Defibrillator Explantation of Probe

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with a defibrillator

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No