Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure

被引：0

作者：

Roberto Galea

Federico De Marco

Adel Aminian

Nicolas Meneveau

Frederic Anselme

Christoph Gräni

Adrian T. Huber

Emmanuel Teiger

Xavier Iriart

Marco Angelillis

Nicolas Brugger

Alessandro Spirito

Noé Corpataux

Anna Franzone

Pascal Vranckx

Urs Fischer

Giovanni Pedrazzini

Francesco Bedogni

Stephan Windecker

Lorenz Räber

Marco Valgimigli

机构：

[1] Bern University Hospital,Department of Cardiology

[2] University of Bern,Department of Cardiology

[3] IRCCS Policlinico San Donato,Department of Cardiology

[4] Centre Hospitalier Universitaire de Charleroi,Department of Cardiology

[5] Besancon University Hospital,Department of Diagnostic, Interventional and Pediatric Radiology

[6] EA3920,Department of Cardiology

[7] University of Burgundy Franche-Comté,Department of Pediatric and Adult Congenital Cardiology

[8] University Hospital of Rouen,Department of Advanced Biomedical Sciences

[9] Bern University Hospital,Department of Cardiology and Critical Care Medicine

[10] University of Bern,Faculty of Medicine and Life Sciences

[11] Henri-Mondor Hospital,Department of Neurology

[12] Public Assistance Hospitals of Paris,Department of Biomedical Sciences

[13] Hôpital Cardiologique du Haut- Lévêque,undefined

[14] Cardiac Thoracic and Vascular Department,undefined

[15] University Federico II University,undefined

[16] Hartcentrum Hasselt,undefined

[17] Jessa Ziekenhuis,undefined

[18] Hasselt University,undefined

[19] Bern University Hospital,undefined

[20] University of Bern,undefined

[21] Cardiocentro Ticino,undefined

[22] University of Italian Switzerland,undefined

来源：

Journal of Cardiovascular Translational Research | 2021年 / 14卷

关键词：

Left atrial appendage closure; Randomized clinical trial; Cardiac computed tomography angiography; Amulet; Watchman; Watchman FLX;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

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.

引用

页码：930 / 940

页数：10

共 96 条

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