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Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).
Official title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2018-06-19
Completion Date
2026-05
Last Updated
2024-05-23
Healthy Volunteers
No
Conditions
Interventions
Amplatzer Amulet for left atrial appendage closure
The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Amplatzer Amulet will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
Watchman/FLX for left atrial appendage closure
The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Watchman/FLX will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
Locations (8)
Centre Hospitalier Universitaire de Charleroi
Charleroi, Belgium
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
Besançon, France
Hopital cardiologique Haut Lévêque CHU de Bordeaux
Bordeaux, France
Hôpital Hôpitaux Universitaires Henri-Mondor
Créteil, France
Centre Hospitalier Universitaire Hôpitaux De Rouen
Rouen, France
IRCCS Policlinico S.Donato
Milan, Italy
Bern University Hospital
Bern, Switzerland/Bern, Switzerland
Department of Cardiology, Cardiocentro Ticino
Lugano, Switzerland