French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Incidence of Appropriate Therapies
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients undergoing EV-ICD implantation
Exclusion Criteria
- •Refusal of consent
Outcomes
Primary Outcomes
Incidence of Appropriate Therapies
Time Frame: 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)
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.
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
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
- Interventions During Follow-up(Through the study completion, an average of 5 years)
- Heart Transplantation(Through the study completion, an average of 5 years)
Investigators
Marijon
Head of Cardiology Division
European Georges Pompidou Hospital