RecruitingNCT06739239

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR


Sponsor

Paris Sudden Death Expertise Center

Enrollment

1,000 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria1

  • All patients undergoing EV-ICD implantation

Exclusion Criteria1

  • Refusal of consent

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Interventions

DEVICEExtra-Vascular Implantable Cardioverter Defibrillator

The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.


Locations(1)

European Georges Pompidou Hospital

Paris, France

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NCT06739239


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