French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR (FOREVER)

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.

Study Overview

• Status: Recruiting
• Conditions: Defibrillators, Implantable; Sudden Cardiac Death Due to Cardiac Arrhythmia
• Intervention / Treatment: Device: Extra-Vascular Implantable Cardioverter Defibrillator

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Eloi MARIJON, MD, PhD; Phone Number: +33 662833848; Email: eloi.marijon@aphp.fr
• Study Contact Backup: Name: Fawzi KERKOURI, MD, MPH; Phone Number: +33 7 67 14 95 58‬; Email: eecmcfawzikerkouri@gmail.com

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • European Georges Pompidou Hospital
    • Contact: Eloi Marijon, Head of Cardiology Department; Phone Number: +33 1 56 09 30 +33 6 62 83 38 48; Email: eloi.marijon@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients implanted with an EV-ICD in France.

Description

Inclusion Criteria:

• All patients undergoing EV-ICD implantation

Exclusion Criteria:

• Refusal of consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients implanted with EV-ICD in France	Device: Extra-Vascular Implantable Cardioverter Defibrillator; The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Appropriate Therapies	The incidence of ICD shocks or ICD ATPs.	Through the study completion, an average of 5 years
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.	Through the study completion, an average of 5 years
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	Through the study completion, an average of 5 years
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.	Through the study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through the study completion, an average of 5 years
Heart Transplantation	The incidence of heart transplant during follow-up	Through the study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Paris Sudden Death Expertise Center
• Collaborators: Hospices Civils de Lyon; University Hospital, Strasbourg, France; University Hospital, Angers; University Hospital, Rouen; Centre Hospitalier Universitaire Dijon; CHU de Reims; Centre Hospitalier Universitaire, Amiens; University Hospital, Montpellier; Central Hospital, Nancy, France; University Hospital, Bordeaux; Poitiers University Hospital; University Hospital, Clermont-Ferrand; University Hospital, Caen; University Hospital, Limoges; Centre Hospitalier Universitaire de Besancon; University Hospital, Grenoble; Rennes University Hospital; University Hospital, Toulouse; University Hospital, Lille; Groupe Hospitalier Pitie-Salpetriere; Centre Hospitalier Annecy Genevois; Hospital St. Joseph, Marseille, France; Universite de La Reunion; Henri Mondor University Hospital; European Georges Pompidou Hospital; University Hospital Center of Martinique; University Hospital of Saint-Etienne; Bichat Hospital; Institut Mutualiste Montsouris; Hospital Ambroise Paré Paris; CHU de la Timone, Marseille, France; Clinique Pasteur Toulouse; Institute Arnault Tzanck, France; Clinique de la Sauvegarde; Clinique du Millenaire; Centre Cardio-Thoracique de Monaco; Clinique Saint Augustin - Bordeaux; Clinique Saint-Gatien - Tours; Hôpital privé Clairval - Marseille; Hôpital Privé de Parly II - Le Chesnay; Institut Jacques Cartier - Massy; Hôpital Privé Les Franciscaines; Médipôle Lyon-Villeurbanne; Clinique St Pierre, Perpignan, France; Hopital Prive Saint Martin - Bordeaux; Hospital of Lens; Central Hospital, Metz Thionville, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: sudden cardiac death; Implantable cardioverter defibrillator; Extravascular Implantable Cardioverter-Defibrillator
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Arrest; Death, Sudden; Death, Sudden, Cardiac; Death; Arrhythmias, Cardiac
• Other Study ID Numbers: 2236443v0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data (IPD) related to the primary and secondary outcomes of the study will be made available. This includes baseline characteristics, procedural details, follow-up outcomes, and information on complications or adverse events. All shared data will exclude any information that could potentially identify participants.
• IPD Sharing Time Frame: From 01/01/2030 to 01/01/2035
• IPD Sharing Access Criteria: Access to the data will be granted upon reasonable request from qualified researchers, with active involvement of the study team in the project.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes