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
This trial does not accept healthy volunteersQualifiers
All patients undergoing EV-ICD implantation
Disqualifiers
Refusal of consent
Trial population
All patients implanted with an EV-ICD in France.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Extra-Vascular Implantable Cardioverter Defibrillator
DeviceThe pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: All patients implanted with EV-ICD in France1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Appropriate Therapies
The incidence of ICD shocks or ICD ATPs.
Time frame
Through the study completion, an average of 5 years2
EV-ICD-related Early Complications (Prior to Hospital Discharge)
The incidence of each complication related to the procedure or the device: pocket hematoma, infection, poor wound healing, inappropriate shocks, lead issues, pneumothorax, pericardial injury, other complications with details.
Time frame
Through the study completion, an average of 5 years3
EV-ICD related Late Complications (After Hospital Discharge)
The incidence of each complication related to the device or genetaor change procedure: infection, pocket hematoma, poor wound healing, inappropriate shocks, lead issues, premature battery depletion, chronic pain, painful pacing, EV-ICD related death
Time frame
Through the study completion, an average of 5 years4
Overall and Specific Mortalities
Incidence of deaths. Causes of Deaths: cardiovascular cause with the main raison leading to death, non-cardiovascular cause with the main raison leading to death, EV-ICD related death with details, and unknown cause.
Time frame
Through the study completion, an average of 5 yearsSecondary outcomes
1
Interventions During Follow-up
Incidence and type of all EV-ICD related intervention. Raison of reintervention: complication, type of complication, generator change and pacing need.
Time frame
Through the study completion, an average of 5 years2
Heart Transplantation
The incidence of heart transplant during follow-up
Time frame
Through the study completion, an average of 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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