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Title: | Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure | Authors: | Galea, Roberto De Marco, Federico Aminian, Adel Meneveau, Nicolas Anselme, Frederic Grani, Christoph Huber, Adrian T. Teiger, Emmanuel Iriart, Xavier Angelillis, Marco Brugger, Nicolas Spirito, Alessandro Corpataux, Noe Franzone, Anna VRANCKX, Pascal Fischer, Urs Pedrazzini, Giovanni Bedogni, Francesco Windecker, Stephan Raber, Lorenz Valgimigli, Marco |
Issue Date: | 2021 | Publisher: | SPRINGER | Source: | Journal of Cardiovascular Translational Research, 14(5), p. 930-940 | Abstract: | 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, 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. | Notes: | Valgimigli, M (corresponding author), Univ Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland.; Valgimigli, M (corresponding author), Cardioctr Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland. marco.valgimigli@cardiocentro.org |
Other: | Valgimigli, M (corresponding author), Univ Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland ; Cardioctr Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland. marco.valgimigli@cardiocentro.org | Keywords: | Left atrial appendage closure; Randomized clinical trial; Cardiac;computed tomography angiography; Amulet; Watchman; Watchman FLX | Document URI: | http://hdl.handle.net/1942/34227 | ISSN: | 1937-5387 | e-ISSN: | 1937-5395 | DOI: | 10.1007/s12265-020-10095-4 | ISI #: | WOS:000642045300001 | Rights: | # The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature 2020 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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s12265-020-10095-4.pdf Restricted Access | Published version | 2.67 MB | Adobe PDF | View/Open Request a copy |
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