French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Incidence of Appropriate Therapies — Through the study completion, an average of 5 years
  The incidence of ICD shocks or ICD ATPs.
• EV-ICD-related Early Complications (Prior to Hospital Discharge) — 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.
• EV-ICD related Late Complications (After Hospital Discharge) — 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
• Overall and Specific Mortalities — 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.

Trial sites (1)

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