French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Recruiting

• Conditions: Defibrillators, Implantable; Sudden Cardiac Death Due to Cardiac Arrhythmia

• Registration Number: NCT06739239
• Lead Sponsor: Paris Sudden Death Expertise Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients undergoing EV-ICD implantation

Exclusion Criteria

• Refusal of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Interventions During Follow-up	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.
Heart Transplantation	Through the study completion, an average of 5 years	The incidence of heart transplant during follow-up

Trial Locations

Locations (1)

European Georges Pompidou Hospital; 🇫🇷 Paris, France