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

NAActive, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 19, 2018

Primary Completion Date

July 9, 2021

Study Completion Date

May 31, 2026

Conditions
Left Atrial Appendage Closure
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.

Trial Locations (8)

3010

Bern University Hospital, Bern

6000

Centre Hospitalier Universitaire de Charleroi, Charleroi

6900

Department of Cardiology, Cardiocentro Ticino, Lugano

20097

IRCCS Policlinico S.Donato, Milan

25030

Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz, Besançon

33600

Hopital cardiologique Haut Lévêque CHU de Bordeaux, Bordeaux

76000

Centre Hospitalier Universitaire Hôpitaux De Rouen, Rouen

94010

Hôpital Hôpitaux Universitaires Henri-Mondor, Créteil

All Listed Sponsors
lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT03399851 - Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO) | Biotech Hunter | Biotech Hunter