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

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).

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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Marco Valgimigli, Prof · Fondazione Cardiocentro Ticino

• Emmanuel Teiger, Prof · Hôpital Hôpitaux Universitaires Henri-Mondor

• Nicolas Meneveau, Prof · Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

• Frederic Anselme, Prof · Centre Hospitalier Universitaire Hôpitaux De Rouen

• Lorenz Räber, Prof · Inselspital, Bern University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-19

Primary Completion

2021-07-09

Completion

2026-05-31

Countries

• Belgium
• France
• Italy
• Switzerland

Study Locations