French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorParis Sudden Death Expertise Center
About this trial
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 criteria
Qualifiers
All patients undergoing EV-ICD implantation
Disqualifiers
Refusal of consent
Trial design
Treatments tested in this trial
- Extra-Vascular Implantable Cardioverter Defibrillator
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Paris Sudden Death Expertise Center
Lead sponsor
European Georges Pompidou Hospital
Sponsor institution
European Georges Pompidou Hospital
Collaborator
University Hospital, Grenoble
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
University Hospital, Rouen
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
Clinique du Millenaire
Collaborator
Institut Mutualiste Montsouris
Collaborator
Groupe Hospitalier Pitie-Salpetriere
Collaborator
University Hospital, Lille
Collaborator
University Hospital, Caen
Collaborator
Hospices Civils de Lyon
Collaborator
CHU de la Timone, Marseille, France
Collaborator
Centre Cardio-Thoracique de Monaco
Collaborator
Hospital of Lens
Collaborator
Institute Arnault Tzanck, France
Collaborator
University Hospital, Strasbourg, France
Collaborator
University Hospital, Limoges
Collaborator
University Hospital, Montpellier
Collaborator
Clinique Pasteur Toulouse
Collaborator
University Hospital, Bordeaux
Collaborator
University Hospital, Toulouse
Collaborator
Institut Jacques Cartier - Massy
Collaborator
Clinique Saint Augustin - Bordeaux
Collaborator
Rennes University Hospital
Collaborator
Clinique de la Sauvegarde
Collaborator
University Hospital of Saint-Etienne
Collaborator
Centre Hospitalier Universitaire, Amiens
Collaborator
Poitiers University Hospital
Collaborator
Clinique Saint-Gatien - Tours
Collaborator
CHU de Reims
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
Hospital St. Joseph, Marseille, France
Collaborator
Centre Hospitalier Annecy Genevois
Collaborator
Clinique St Pierre, Perpignan, France
Collaborator
Bichat Hospital
Collaborator
Universite de La Reunion
Collaborator
University Hospital Center of Martinique
Collaborator
Henri Mondor University Hospital
Collaborator
University Hospital, Angers
Collaborator
Central Hospital, Nancy, France
Collaborator
Hôpital privé Clairval - Marseille
Collaborator
Médipôle Lyon-Villeurbanne
Collaborator
Hôpital Privé Les Franciscaines
Collaborator
Hospital Ambroise Paré Paris
Collaborator
Central Hospital, Metz Thionville, France
Collaborator
Hopital Prive Saint Martin - Bordeaux
Collaborator
Hôpital Privé de Parly II - Le Chesnay
Collaborator
Source ClinicalTrials.gov