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| Name | Class |
|---|---|
| European Georges Pompidou Hospital | OTHER |
| University Hospital, Grenoble | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| University Hospital, Rouen |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients implanted with EV-ICD in France |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-Vascular Implantable Cardioverter Defibrillator | Device | The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients implanted with an EV-ICD in France.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eloi MARIJON, MD, PhD | Contact | 662833848 | +33 | eloi.marijon@aphp.fr |
| Fawzi KERKOURI, MD, MPH | Contact | 7 67 14 95 58 | +33 | eecmcfawzikerkouri@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Georges Pompidou Hospital | Recruiting | Paris | 75015 | France |
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.
From 01/01/2030 to 01/01/2035
Access to the data will be granted upon reasonable request from qualified researchers, with active involvement of the study team in the project.
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| 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 |
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The incidence of heart transplant during follow-up |
| Through the study completion, an average of 5 years |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |