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Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure
Journal of Cardiovascular Translational Research ( IF 3.4 ) Pub Date : 2021-04-21 , DOI: 10.1007/s12265-020-10095-4
Roberto Galea 1 , Federico De Marco 2 , Adel Aminian 3 , Nicolas Meneveau 4 , Frederic Anselme 5 , Christoph Gräni 1 , Adrian T Huber 6 , Emmanuel Teiger 7 , Xavier Iriart 8 , Marco Angelillis 9 , Nicolas Brugger 1 , Alessandro Spirito 1 , Noé Corpataux 1 , Anna Franzone 10 , Pascal Vranckx 11, 12 , Urs Fischer 13 , Giovanni Pedrazzini 14, 15 , Francesco Bedogni 2 , Stephan Windecker 1 , Lorenz Räber 1 , Marco Valgimigli 1, 14
Affiliation  

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The “Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure” (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.



中文翻译:

Swiss-Apero 随机临床试验的设计和基本原理:Amplatzer Amulet 与 Watchman 装置在接受左心耳闭合术的患者中的比较

左心耳闭合 (LAAC) 后常规评估残留或新获得的泄漏。Watchman 和 Amulet 是 LAAC 最常用的两种装置,但迄今为止还没有随机研究评估它们在干预后的比较泄漏率。“Amplatzer Amulet 与 Watchman 装置在接受左心耳闭合术的患者中的比较”(Swiss-Apero,clinicaltrial.gov NCT03399851)是一项学术赞助的多中心随机临床试验,在接受临床适应症的患者中比较 Amulet 与 Watchman/FLX 装置LAAC。该研究旨在评估 Amulet 与 Watchman/FLX 在成像核心实验室干预后 45 天(主要终点)和 13 个月(次要终点)时通过心脏计算机断层扫描血管造影(CCTA)检测到的泄漏方面的优势。

更新日期:2021-04-21
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