Trials / Recruiting
RecruitingNCT06739239
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Paris Sudden Death Expertise Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Implantable cardioverter-defibrillators (ICDs) are widely recognized for their efficacy in reducing the risk of sudden cardiac death in high-risk patients. Nonetheless, there remains significant scope for improving outcomes through advancements in device technology and design. The extravascular cardioverter-defibrillator (EV-ICD) represents such an innovation, offering key advantages over other ICD systems. It incorporates a lead positioned in the substernal space, enabling the delivery of pause-prevention security pacing, antitachycardia pacing, and defibrillation energy similar to that provided by conventional transvenous ICDs. Previous studies have demonstrated that EV-ICDs can be implanted safely and are capable of terminating majority of induced ventricular arrhythmias during implantation; however, follow-up data are limited to highly experienced selected centers and over a relatively small follow-up period (6-month follow-up). The FOREVER cohort study, initiated by the French Institute of Health and Medical Research, aims to evaluate the EV-ICD use in France. This nationwide evaluation will provide an exhaustive collection of all EV-ICD implantations in France, offering valuable real-world evidence on the long-term safety and efficacy of the device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Extra-Vascular Implantable Cardioverter Defibrillator | The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally. |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
- First posted
- 2024-12-18
- Last updated
- 2024-12-20
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06739239. Inclusion in this directory is not an endorsement.