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ACTIVE NOT RECRUITING
NCT03399851
NA

Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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