Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy

NAActive, not recruitingINTERVENTIONAL
Enrollment

609

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

May 1, 2026

Study Completion Date

November 1, 2026

Conditions
Atrial FibrillationAnticoagulants and Bleeding Disorders
Interventions
DEVICE

Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)

Currently, there are two devices available on the Dutch market, Watchman and Amulet. After randomization to the intervention arm, additional randomization for type of device will follow. If the amount of procedures is too small to implant two devices, the centre will implant a device of choice.

Trial Locations (14)

6525 GA

Radboud UMC, Nijmegen

6229 HX

Maastricht UMC, Maastricht

4818 CK

Amphia Hospital, Breda

1091 AC

OLVG, Amsterdam

1105 AZ

Amsterdam UMC, Amsterdam

3435 CM

St Antonius Hospital, Nieuwegein

7512 KZ

Medical Spectrum Twente, Enschede

8025 BT

Isala Clinics, Zwolle

8934 AD

Medical Center Leeuwarden, Leeuwarden

2333 ZA

Leiden UMC, Leiden

3015 GD

Erasmus MC, Rotterdam

2545 AA

Haga Hospital, The Hague

9713 GZ

UMC Groningen, Groningen

3584 CX

UMC Utrecht, Utrecht

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

R&D Cardiologie

OTHER