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French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• All patients undergoing EV-ICD implantation

Locations
Other Locations
France
European Georges Pompidou Hospital
RECRUITING
Paris
Contact Information
Primary
Eloi MARIJON, MD, PhD
eloi.marijon@aphp.fr
662833848
Backup
Fawzi KERKOURI, MD, MPH
eecmcfawzikerkouri@gmail.com
7 67 14 95 58‬
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 1000
Treatments
All patients implanted with EV-ICD in France
Related Therapeutic Areas
Sponsors
Collaborators: Clinique Saint Augustin - Bordeaux, Centre Hospitalier Annecy Genevois, University Hospital, Montpellier, Clinique du Millenaire, Médipôle Lyon-Villeurbanne, University Hospital, Caen, Hospices Civils de Lyon, Central Hospital, Nancy, France, Hopital Prive Saint Martin - Bordeaux, Clinique Pasteur Toulouse, Centre Hospitalier Universitaire Dijon, Hospital Ambroise Paré Paris, Groupe Hospitalier Pitie-Salpetriere, Poitiers University Hospital, Institute Arnault Tzanck, France, University Hospital, Limoges, Institut Mutualiste Montsouris, Centre Hospitalier Universitaire de Besancon, CHU de Reims, University Hospital, Angers, Institut Jacques Cartier - Massy, University Hospital, Toulouse, University Hospital, Bordeaux, European Georges Pompidou Hospital, University Hospital, Strasbourg, France, Clinique St Pierre, Perpignan, France, Bichat Hospital, Clinique Saint-Gatien - Tours, Rennes University Hospital, University Hospital, Clermont-Ferrand, University Hospital, Lille, University Hospital Center of Martinique, University Hospital of Saint-Etienne, Henri Mondor University Hospital, Centre Cardio-Thoracique de Monaco, Hospital St. Joseph, Marseille, France, Central Hospital, Metz Thionville, France, Hôpital privé Clairval - Marseille, CHU de la Timone, Marseille, France, Hospital of Lens, Clinique de la Sauvegarde, Hôpital Privé de Parly II - Le Chesnay, University Hospital, Grenoble, Centre Hospitalier Universitaire, Amiens, University Hospital, Rouen, Universite de La Reunion, Hôpital Privé Les Franciscaines
Leads: Paris Sudden Death Expertise Center

This content was sourced from clinicaltrials.gov