Observational study on a new type of implantable defibrillator
Official title: French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Run by Paris Sudden Death Expertise Center · NCT06739239 · Data updated 2026-11-12
This study looks at a new type of implantable defibrillator to see how well it works in preventing sudden cardiac death in patients who are at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Paris Sudden Death Expertise Center Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | December 20, 2024 |
| Trial ID | NCT06739239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients who are undergoing implantation of an extravascular implantable cardioverter-defibrillator.
✕Probably not a fit
Patients who refuse consent for participation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on the extravascular implantable cardioverter-defibrillator (EV-ICD), which is designed to reduce the risk of sudden cardiac death in high-risk patients. The EV-ICD features a lead positioned in the substernal space, allowing for advanced pacing and defibrillation capabilities. While previous studies have shown that EV-ICDs can be safely implanted and effectively terminate ventricular arrhythmias, this study aims to gather more extensive follow-up data from a broader patient population. The study is observational, meaning it will monitor outcomes without assigning specific interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients at risk of sudden cardiac death through enhanced defibrillator technology.
How similar studies have gone: Previous studies have shown that EV-ICDs can be safely implanted and are effective, but this study aims to expand on limited follow-up data from selected centers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing EV-ICD implantation Exclusion Criteria: * Refusal of consent
Where it's running
-
European Georges Pompidou Hospital
Paris, France Recruiting
Study contacts
- Study coordinator: Eloi MARIJON, MD, PhD
- Email: eloi.marijon@aphp.fr
- Phone: 662833848
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.