Observational study on a new type of implantable defibrillator
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Paris Sudden Death Expertise Center · NCT06739239
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Paris Sudden Death Expertise Center (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06739239 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are undergoing implantation of an extravascular implantable cardioverter-defibrillator.
Not a fit: Patients who refuse consent for participation will not benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing EV-ICD implantation Exclusion Criteria: * Refusal of consent
Where this trial is running
Paris
- European Georges Pompidou Hospital — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Eloi MARIJON, MD, PhD
- Email: eloi.marijon@aphp.fr
- Phone: 662833848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Defibrillators, Implantable, Sudden Cardiac Death Due to Cardiac Arrhythmia, Implantable cardioverter defibrillator, sudden cardiac death, Extravascular Implantable Cardioverter-Defibrillator