Clinical trial NCT06739239: French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Official title: French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Defibrillators, Implantable
Sudden Cardiac Death Due to Cardiac Arrhythmia
Keywords: Implantable cardioverter defibrillator
sudden cardiac death
Extravascular Implantable Cardioverter-Defibrillator
Lead sponsor: Paris Sudden Death Expertise Center
Sponsor class: OTHER
Collaborators: name: European Georges Pompidou Hospital
name: University Hospital, Grenoble
name: University Hospital, Clermont-Ferrand
name: University Hospital, Rouen
name: Centre Hospitalier Universitaire de Besancon
name: Clinique du Millenaire
name: Institut Mutualiste Montsouris
name: Groupe Hospitalier Pitie-Salpetriere
name: University Hospital, Lille
name: University Hospital, Caen
name: Hospices Civils de Lyon
name: CHU de la Timone, Marseille, France
name: Centre Cardio-Thoracique de Monaco
name: Hospital of Lens
name: Institute Arnault Tzanck, France
name: University Hospital, Strasbourg, France
name: University Hospital, Limoges
name: University Hospital, Montpellier
name: Clinique Pasteur Toulouse
name: University Hospital, Bordeaux
name: University Hospital, Toulouse
name: Institut Jacques Cartier - Massy
name: Clinique Saint Augustin - Bordeaux
name: Rennes University Hospital
name: Clinique de la Sauvegarde
name: University Hospital of Saint-Etienne
name: Centre Hospitalier Universitaire, Amiens
name: Poitiers University Hospital
name: Clinique Saint-Gatien - Tours
name: CHU de Reims
name: Centre Hospitalier Universitaire Dijon
name: Hospital St. Joseph, Marseille, France
name: Centre Hospitalier Annecy Genevois
name: Clinique St Pierre, Perpignan, France
name: Bichat Hospital
name: Universite de La Reunion
name: University Hospital Center of Martinique
name: Henri Mondor University Hospital
name: University Hospital, Angers
name: Central Hospital, Nancy, France
name: Hôpital privé Clairval - Marseille
name: Médipôle Lyon-Villeurbanne
name: Hôpital Privé Les Franciscaines
name: Hospital Ambroise Paré Paris
name: Central Hospital, Metz Thionville, France
name: Hopital Prive Saint Martin - Bordeaux
name: Hôpital Privé de Parly II - Le Chesnay
First posted: 2024-12-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients implanted with an EV-ICD in France.

Brief 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 criteria: Inclusion Criteria:

* All patients undergoing EV-ICD implantation

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: Incidence of Appropriate Therapies
timeFrame: Through the study completion, an average of 5 years
measure: EV-ICD-related Early Complications (Prior to Hospital Discharge)
timeFrame: Through the study completion, an average of 5 years
measure: EV-ICD related Late Complications (After Hospital Discharge)
timeFrame: Through the study completion, an average of 5 years
measure: Overall and Specific Mortalities
timeFrame: Through the study completion, an average of 5 years
Secondary outcomes:
measure: Interventions During Follow-up
timeFrame: Through the study completion, an average of 5 years
measure: Heart Transplantation
timeFrame: Through the study completion, an average of 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: European Georges Pompidou Hospital
Study officials:
References: