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

Atrial Appendage / diagnostic imaging Atrial Fibrillation / diagnostic imaging Cardiac Catheterization / adverse effects Computed Tomography Angiography Europe Humans Randomized Controlled Trials as Topic Research Design Time Factors Tomography, X-Ray Computed Treatment Outcome
Amulet Cardiac computed tomography angiography Left atrial appendage closure Randomized clinical trial Watchman Watchman FLX

Journal

Journal of cardiovascular translational research
ISSN: 1937-5395
Titre abrégé: J Cardiovasc Transl Res
Pays: United States
ID NLM: 101468585

Informations de publication

Date de publication:
10 2021
Historique:
received: 09 07 2020
accepted: 16 12 2020
pubmed: 23 4 2021
medline: 9 2 2022
entrez: 22 4 2021
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1007/s12265-020-10095-4 PMID: 33884564
pubmed: 33884564
doi: 10.1007/s12265-020-10095-4
pii: 10.1007/s12265-020-10095-4
doi:

Banques de données

ClinicalTrials.gov
['NCT03399851']

Types de publication

Clinical Trial Protocol Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

930-940

Informations de copyright

© 2020. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.

Références

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Auteurs

Roberto Galea (R)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Federico De Marco (F)

Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Adel Aminian (A)

Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.

Nicolas Meneveau (N)

Besancon University Hospital, EA3920, University of Burgundy Franche-Comté, Besancon, France.

Frederic Anselme (F)

Department of Cardiology, University Hospital of Rouen, Rouen, France.

Christoph Gräni (C)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Adrian T Huber (AT)

Department of Diagnostic, Interventional and Pediatric Radiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Emmanuel Teiger (E)

Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France.

Xavier Iriart (X)

Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut- Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France.

Marco Angelillis (M)

Cardiac Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Nicolas Brugger (N)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Alessandro Spirito (A)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Noé Corpataux (N)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Anna Franzone (A)

Department of Advanced Biomedical Sciences, University Federico II University, Naples, Italy.

Pascal Vranckx (P)

Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.
Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.

Urs Fischer (U)

Department of Neurology, Bern University Hospital, University of Bern, Bern, Switzerland.

Giovanni Pedrazzini (G)

Cardiocentro Ticino, Via Tesserete 48, 6900, Lugano, Switzerland.
Department of Biomedical Sciences, University of Italian Switzerland, 6900, Lugano, Switzerland.

Francesco Bedogni (F)

Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.

Stephan Windecker (S)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Lorenz Räber (L)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Marco Valgimigli (M)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. marco.valgimigli@cardiocentro.org.
Cardiocentro Ticino, Via Tesserete 48, 6900, Lugano, Switzerland. marco.valgimigli@cardiocentro.org.
ORCID: 0000-0002-4353-7110

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Classifications MeSH

questionsmedicales.fr › Système cardiovasculaire › Coeur › Atrium du coeur › Auricule de l'atrium › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Troubles du rythme cardiaque › Fibrillation auriculaire › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Techniques d'investigation › Cathétérisme › Cathétérisme cardiaque › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Tomographie à rayons X › Tomodensitométrie › Angiographie par tomodensitométrie › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Régions géographiques › Europe › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Phénomènes physiques › Temps › Facteurs temps › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Tomographie à rayons X › Tomodensitométrie › Design and Rationale of the Swiss-Apero...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Design and Rationale of the Swiss-Apero...