血管外植入式心律转复除颤器上市后登记的设计：启蒙研究

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart Rhythm O2 Pub Date : 2025-01-01 DOI:10.1016/j.hroo.2024.09.022

Lucas V.A. Boersma MD, PhD , Anish Amin MD , Nicolas Clémenty MD, PhD , David Duncker MD , Gregory Engel MD , Laurence Epstein MD , Vikas Kuriachan MD , Camille Frazier-Mills MD , Marianne Gwechenberger MD , Nobuhiro Nishii MD , Jeff Lande PhD , Christopher Wiggenhorn PhD , Ian Crozier MB ChB

{"title":"血管外植入式心律转复除颤器上市后登记的设计：启蒙研究","authors":"Lucas V.A. Boersma MD, PhD , Anish Amin MD , Nicolas Clémenty MD, PhD , David Duncker MD , Gregory Engel MD , Laurence Epstein MD , Vikas Kuriachan MD , Camille Frazier-Mills MD , Marianne Gwechenberger MD , Nobuhiro Nishii MD , Jeff Lande PhD , Christopher Wiggenhorn PhD , Ian Crozier MB ChB","doi":"10.1016/j.hroo.2024.09.022","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>ClinicalTrials.gov ID</h3><div><span><span>NCT06048731</span><svg><path></path></svg></span></div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"6 1","pages":"Pages 64-69"},"PeriodicalIF":2.5000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study\",\"authors\":\"Lucas V.A. Boersma MD, PhD , Anish Amin MD , Nicolas Clémenty MD, PhD , David Duncker MD , Gregory Engel MD , Laurence Epstein MD , Vikas Kuriachan MD , Camille Frazier-Mills MD , Marianne Gwechenberger MD , Nobuhiro Nishii MD , Jeff Lande PhD , Christopher Wiggenhorn PhD , Ian Crozier MB ChB\",\"doi\":\"10.1016/j.hroo.2024.09.022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>ClinicalTrials.gov ID</h3><div><span><span>NCT06048731</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":29772,\"journal\":{\"name\":\"Heart Rhythm O2\",\"volume\":\"6 1\",\"pages\":\"Pages 64-69\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Heart Rhythm O2\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2666501824003271\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart Rhythm O2","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666501824003271","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

摘要

研究背景：胸骨下置铅的血管外植入式心律转复除颤器（EV-ICD）已被证明可以在血管外安全有效地终止室性心律失常。EV-ICD系统采用了一种新颖的不合适的减震算法，其在实际环境中的性能还有待研究。enlightenment研究的目的：EV-ICD批准后注册的目的是提供EV-ICD系统在设备生命周期内的真实临床实践中的安全性和性能的综合衡量。方法：启迪研究是一项全球性、前瞻性、观察性、多中心、批准后研究，利用制造商的产品监督注册。将包括在参与中心植入Aurora EV-ICD系统的符合条件的患者。随访临床数据将在设备的整个生命周期中大约每6个月收集一次，招募至少500名患者。研究的主要终点是植入后5年的主要系统相关无并发症生存率，最低阈值为79%。该研究还将描述设备的性能，包括但不限于系统或程序相关并发症的自由、抗心动过速起搏的性能、传感和检测的特性、不适当的治疗、休克效果、电池耗尽和系统修订。启发研究：EV-ICD批准后注册将检查EV-ICD上市后系统的实际性能。此外，该研究将允许对ev - icd相关并发症、器械修改和长期（5年）种植期间的拔牙进行强有力的评估

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

查看原文本刊更多论文

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.