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French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Recruiting
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • All patients undergoing EV-ICD implantation

Exclusion Criteria:

  • Refusal of consent

Study details
    Defibrillators
    Implantable
    Sudden Cardiac Death Due to Cardiac Arrhythmia

NCT06739239

Paris Sudden Death Expertise Center

15 October 2025

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