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Recruiting NCT06739239

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

— Observational Defibrillators, Implantable Sudden Cardiac Death Due to Cardiac Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extra-Vascular Implantable Cardioverter Defibrillator.
Who it may be relevant to
Registry conditions: Defibrillators, Implantable, Sudden Cardiac Death Due to Cardiac Arrhythmia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Extra-Vascular Implantable Cardioverter Defibrillator
    The pulse generator is implanted along the patient's left midaxillary line, and the lead is positioned substernally.

Primary outcome measures

  • Incidence of Appropriate Therapies [Time frame: Through the study completion, an average of 5 years]
  • EV-ICD-related Early Complications (Prior to Hospital Discharge) [Time frame: Through the study completion, an average of 5 years]
  • EV-ICD related Late Complications (After Hospital Discharge) [Time frame: Through the study completion, an average of 5 years]
  • Overall and Specific Mortalities [Time frame: Through the study completion, an average of 5 years]
Secondary outcome measures (2)
  • Interventions During Follow-up [Time frame: Through the study completion, an average of 5 years]
  • Heart Transplantation [Time frame: Through the study completion, an average of 5 years]

Eligibility criteria

Inclusion criteria

  • All patients undergoing EV-ICD implantation

Exclusion criteria

  • Refusal of consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • European Georges Pompidou Hospital — Paris

Identifiers

NCT: NCT06739239 · 2236443v0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗