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

Galea, Roberto; De Marco, Federico; Aminian, Adel; Meneveau, Nicolas; Anselme, Frederic; Gräni, Christoph; Huber, Adrian T.; Teiger, Emmanuel; Iriart, Xavier; Angelillis, Marco; Brugger, Nicolas; Spirito, Alessandro; Corpataux, Noé; Franzone, Anna; Vranckx, Pascal; Fischer, Urs; Pedrazzini, Giovanni; Bedogni, Francesco; Windecker, Stephan; Räber, Lorenz; ... (2021). Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (In Press). Journal of cardiovascular translational research JCTR Springer 10.1007/s12265-020-10095-4

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic, Interventional and Paediatric Radiology

UniBE Contributor:

Galea, Roberto; Gräni, Christoph; Huber, Adrian Thomas; Brugger, Nicolas Jacques; Spirito, Alessandro; Fischer, Urs; Windecker, Stephan; Räber, Lorenz and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1937-5387

Publisher:

Springer

Language:

English

Submitter:

Maria de Fatima Henriques Bernardo

Date Deposited:

10 May 2021 14:20

Last Modified:

10 May 2021 14:20

Publisher DOI:

10.1007/s12265-020-10095-4

PubMed ID:

33884564

Uncontrolled Keywords:

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

BORIS DOI:

10.48350/156025

URI:

https://boris.unibe.ch/id/eprint/156025

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