Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
J Cardiovasc Transl Res. 2021 Oct;14(5):930-940. doi: 10.1007/s12265-020-10095-4. Epub 2021 Apr 21.
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.
经左心耳封堵 (LAAC) 后，通常会对残余或新出现的漏口进行评估。Watchman 和 Amulet 是两种最常使用的 LAAC 装置，但迄今为止尚无随机研究评估介入治疗后它们的漏口率。“在接受左心耳封堵术的患者中比较 Amplatzer Amulet 与 Watchman 装置”（瑞士-Apero，clinicaltrial.gov NCT03399851）是一项由学术机构赞助的多中心、随机临床试验，比较了 Amulet 与 Watchman/FLX 装置在临床需要 LAAC 的患者中的应用。该研究旨在评估 Amulet 在经影像学核心实验室评估的 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) 检测到的漏口方面优于 Watchman/FLX。瑞士-Apero 研究是第一项比较 Amulet 和 Watchman/FLX 术后漏口发生率的随机临床试验，采用 CCTA 进行评估。
