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NCT Number: NCT06739239

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

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.

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Key information

Conditions

Defibrillators, Implantable Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Due to Cardiac Arrhythmia

Sex eligibility

All sexes

Study type

Observational

Primary location

European Georges Pompidou Hospital

Paris, 75015, France

Location status: Recruiting

Location contact

Eloi Marijon, Head of Cardiology Department

CONTACT

[email protected]

+33 6 62 83 38 48 ext. +33 1 56 09 30

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing EV-ICD implantation

Exclusion criteria

  • Refusal of consent

Treatment and study plan

Extra-Vascular Implantable Cardioverter Defibrillator

Device

The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.

Primary outcomes

  1. Incidence of Appropriate Therapies

    Time frame: Through the study completion, an average of 5 years

    The incidence of ICD shocks or ICD ATPs.

  2. EV-ICD-related Early Complications (Prior to Hospital Discharge)

    Time frame: Through the study completion, an average of 5 years

    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.

  3. EV-ICD related Late Complications (After Hospital Discharge)

    Time frame: Through the study completion, an average of 5 years

    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

  4. Overall and Specific Mortalities

    Time frame: Through the study completion, an average of 5 years

    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.

Secondary outcomes

  1. Interventions During Follow-up

    Time frame: Through the study completion, an average of 5 years

    Incidence and type of all EV-ICD related intervention. Raison of reintervention: complication, type of complication, generator change and pacing need.

  2. Heart Transplantation

    Time frame: Through the study completion, an average of 5 years

    The incidence of heart transplant during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Eloi MARIJON, MD, PhD

CONTACT

[email protected]

662833848 ext. +33

Fawzi KERKOURI, MD, MPH

CONTACT

[email protected]

7 67 14 95 58‬ ext. +33

Sponsors and collaborators

Lead sponsor

Paris Sudden Death Expertise Center

Other

Collaborators

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

Registry information

Acronym: FOREVER

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Dec 18, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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