French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

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

• Defibrillators, Implantable
• Sudden Cardiac Death Due to Cardiac Arrhythmia

Interventions

DEVICE

Extra-Vascular Implantable Cardioverter Defibrillator

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

Sponsors & Collaborators

• European Georges Pompidou Hospital

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Clinique du Millenaire

  collaborator OTHER

• Institut Mutualiste Montsouris

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• CHU de la Timone, Marseille, France

  collaborator UNKNOWN

• Centre Cardio-Thoracique de Monaco

  collaborator UNKNOWN

• Hospital of Lens

  collaborator UNKNOWN

• Institute Arnault Tzanck, France

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• University Hospital, Limoges

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Clinique Pasteur Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Institut Jacques Cartier - Massy

  collaborator UNKNOWN

• Clinique Saint Augustin - Bordeaux

  collaborator UNKNOWN

• Rennes University Hospital

  collaborator OTHER

• Clinique de la Sauvegarde

  collaborator OTHER

• University Hospital of Saint-Etienne

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Clinique Saint-Gatien - Tours

  collaborator UNKNOWN

• CHU de Reims

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Hospital St. Joseph, Marseille, France

  collaborator OTHER

• Centre Hospitalier Annecy Genevois

  collaborator OTHER

• Clinique St Pierre, Perpignan, France

  collaborator UNKNOWN

• Bichat Hospital

  collaborator OTHER

• Universite de La Reunion

  collaborator OTHER

• University Hospital Center of Martinique

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Central Hospital, Nancy, France

  collaborator OTHER

• Hôpital privé Clairval - Marseille

  collaborator UNKNOWN

• Médipôle Lyon-Villeurbanne

  collaborator OTHER

• Hôpital Privé Les Franciscaines

  collaborator OTHER

• Hospital Ambroise Paré Paris

  collaborator OTHER

• Central Hospital, Metz Thionville, France

  collaborator UNKNOWN

• Hopital Prive Saint Martin - Bordeaux

  collaborator UNKNOWN

• Hôpital Privé de Parly II - Le Chesnay

  collaborator OTHER

• Paris Sudden Death Expertise Center

  lead OTHER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Device

Yes

Countries

• France

Study Locations