CompletedNot Applicable

Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

France143 participantsStarted 2020-02-03

Plain-language summary

This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement. * Consent for participation * Affiliation to the French social security system Exclusion Criteria: * Atrial Fibrillation without effective anti-coagulation treatments. * Severe Aortic valve stenosis * Stroke occurred in the previous month * Hemodynamic instability contraindicating the high energy shock * Contraindication for anesthesia * Pregnant or breastfeeding women * Communication difficulties or neuropsychiatric disorder * Patients under protection of the adults (guardianship, curators or safeguard of justice)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.

Timeframe: 4 hours

Trial details

NCT IDNCT04206371

SponsorCMC Ambroise Paré

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-19

Results submitted2026-04-22

View on ClinicalTrials.gov More Implantable Cardioverter-Defibrillators trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.