French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
NCT ID: NCT06739239
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-02-01
2030-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All patients implanted with EV-ICD in France
Extra-Vascular Implantable Cardioverter Defibrillator
The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
Interventions
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Extra-Vascular Implantable Cardioverter Defibrillator
The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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European Georges Pompidou Hospital
OTHER
University Hospital, Grenoble
OTHER
University Hospital, Clermont-Ferrand
OTHER
University Hospital, Rouen
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Clinique du Millenaire
OTHER
Institut Mutualiste Montsouris
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
University Hospital, Lille
OTHER
University Hospital, Caen
OTHER
Hospices Civils de Lyon
OTHER
CHU de la Timone, Marseille, France
UNKNOWN
Centre Cardio-Thoracique de Monaco
UNKNOWN
Hospital of Lens
UNKNOWN
Institute Arnault Tzanck, France
OTHER
University Hospital, Strasbourg, France
OTHER
University Hospital, Limoges
OTHER
University Hospital, Montpellier
OTHER
Clinique Pasteur Toulouse
OTHER
University Hospital, Bordeaux
OTHER
University Hospital, Toulouse
OTHER
Institut Jacques Cartier - Massy
UNKNOWN
Clinique Saint Augustin - Bordeaux
UNKNOWN
Rennes University Hospital
OTHER
Clinique de la Sauvegarde
OTHER
University Hospital of Saint-Etienne
OTHER
Centre Hospitalier Universitaire, Amiens
OTHER
Poitiers University Hospital
OTHER
Clinique Saint-Gatien - Tours
UNKNOWN
CHU de Reims
OTHER
Centre Hospitalier Universitaire Dijon
OTHER
Hospital St. Joseph, Marseille, France
OTHER
Centre Hospitalier Annecy Genevois
OTHER
Clinique St Pierre, Perpignan, France
UNKNOWN
Bichat Hospital
OTHER
Universite de La Reunion
OTHER
University Hospital Center of Martinique
OTHER
Henri Mondor University Hospital
OTHER
University Hospital, Angers
OTHER_GOV
Central Hospital, Nancy, France
OTHER
Hôpital privé Clairval - Marseille
UNKNOWN
Médipôle Lyon-Villeurbanne
OTHER
Hôpital Privé Les Franciscaines
OTHER
Hospital Ambroise Paré Paris
OTHER
Central Hospital, Metz Thionville, France
UNKNOWN
Hopital Prive Saint Martin - Bordeaux
UNKNOWN
Hôpital Privé de Parly II - Le Chesnay
OTHER
Paris Sudden Death Expertise Center
OTHER
Responsible Party
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Marijon
Head of Cardiology Division
Locations
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European Georges Pompidou Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Eloi Marijon, Head of Cardiology Department
Role: primary
Other Identifiers
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2236443v0
Identifier Type: -
Identifier Source: org_study_id