Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study.

Background: The extravascular implantable cardioverter-defibrillator (EV-ICD) with substernal lead placement has been shown to terminate ventricular arrhythmias safely and effectively while being outside the vasculature. The performance of the EV-ICD system with a novel inappropriate shock-reducing algorithm in a real-world setting has yet to be investigated. Objective: The objective of the Enlighten Study: the EV-ICD Post-Approval Registry is to provide a comprehensive measure of the safety and performance of the EV-ICD system in real-world clinical practice over the lifetime of the device. Methods: The Enlighten Study is a global, prospective, observational, multicenter, post-approval study utilizing the manufacturer's Product Surveillance Registry. Eligible patients implanted with an Aurora EV-ICD system at participating centers will be included. Follow-up clinical data will be collected approximately every 6 months throughout the lifetime of the device, enrolling a minimum of 500 patients. Results: The primary endpoint of the study is major system-related complication-free survival at 5 years post-implantation, with a minimum threshold of >79%. The study will also characterize device performance that includes, but is not limited to, freedom from system- or procedure-related complications, performance of antitachycardia pacing, characterization of sensing and detection, inappropriate therapy, shock effectiveness, battery depletion, and system revisions. Conclusion: The Enlighten Study: the EV-ICD Post-Approval Registry will examine the real-world performance of the post-market EV-ICD system. Additionally, this study will allow for a robust assessment of EV-ICD-related complications, device revisions, and extractions over chronic (>5 years) implant durations. ClinicalTrialsgov ID: NCT06048731.