Nationwide Study of Extra-Vascular Implantable Cardioverter Defibrillators EV-ICD Use in France to Assess Long-Term Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the use of the extravascular implantable cardioverter-defibrillator EV-ICD for patients at risk of sudden cardiac death due to cardiac arrhythmia. This observational study aims to collect real-world data on the long-term safety and effectiveness of this newer device design, which offers advantages over traditional implantable cardioverter-defibrillators by placing the lead in the substernal space. The study is conducted nationwide in France to provide comprehensive evidence beyond previous smaller, specialized center trials. The EV-ICD device studied involves implanting a pulse generator along the left midaxillary line with a lead positioned substernally. This device is designed to deliver pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to conventional ICDs but with potentially improved outcomes. The study includes all patients receiving an EV-ICD implant in France and observes them over an average follow-up period of five years. Participants will be monitored throughout the study period for appropriate device therapies, early and late complications related to the EV-ICD, and overall mortality. Additional outcomes include interventions during follow-up and heart transplantation rates. Data collection will occur from implantation through hospital discharge and continue for about five years to assess long-term safety and effectiveness in a real-world setting.

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR