Boersma Lucas V A, Amin Anish, Clémenty Nicolas, Duncker David, Engel Gregory, Epstein Laurence, Kuriachan Vikas, Frazier-Mills Camille, Gwechenberger Marianne, Nishii Nobuhiro, Lande Jeff, Wiggenhorn Christopher, Crozier Ian
Cardiology Department, St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands.
Cardiology Department, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Heart Rhythm O2. 2024 Oct 16;6(1):64-69. doi: 10.1016/j.hroo.2024.09.022. eCollection 2025 Jan.
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.
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.
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.
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.
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.
NCT06048731.
已证明采用胸骨后导线放置的血管外植入式心脏复律除颤器（EV-ICD）在血管系统外时能安全有效地终止室性心律失常。具有新型减少不适当电击算法的EV-ICD系统在实际应用中的性能尚未得到研究。
“启发研究：EV-ICD批准后注册研究”的目的是全面衡量EV-ICD系统在实际临床实践中整个设备使用寿命期间的安全性和性能。
“启发研究”是一项全球性、前瞻性、观察性、多中心、批准后研究，利用制造商的产品监测注册系统。将纳入在参与中心植入Aurora EV-ICD系统的符合条件的患者。在设备的整个使用寿命期间，大约每6个月收集一次随访临床数据，至少招募5百名患者。
该研究的主要终点是植入后5年无重大系统相关并发症的生存率，最低阈值>79%。该研究还将描述设备性能，包括但不限于无系统或手术相关并发症、抗心动过速起搏性能、感知和检测特征、不适当治疗、电击效果、电池耗尽以及系统修订。
“启发研究：EV-ICD批准后注册研究”将检查上市后EV-ICD系统的实际性能。此外，这项研究将对慢性（>5年）植入期内与EV-ICD相关的并发症、设备修订和取出情况进行有力评估。
NCT06048731。
