ATLAAC - Surgical left atrial appendage closure with and without postoperative anticoagulant therapy in patients with atrial fibrillation undergoing cardiac surgery: a randomized non-inferiority trial

Study design

Prospective, randomized, open, blinded-endpoint (PROBE) multicenter trial.

About the project

The ATLAAC trial (Anticoagulant Therapy after Left Atrial Appendage Closure)

Atrial fibrillation (AF) significantly increases the risk of stroke and systemic emboli. Long-term oral anticoagulation (OAC) is recommended for most AF patients, despite the bleeding risk. Surgical left atrial appendage (LAA) closure reduces stroke and emboli risk. However, current guidelines recommend continuing OAC postoperatively.

This definitive randomized trial investigating the risk of stroke, systemic emboli, and bleeding with and without OAC in patients, who have undergone surgical LAA closure, will determine whether OAC can safely be discontinued in these patients.

Objective(s)

Primary objective

  • to investigate the risk of thromboembolic events and bleeding events with and without OAC in patients with AF, who have previously undergone surgical LAA closure.

Secondary objectives

  • to investigate the degree of sufficiency of LAA closure in patients with AF, who have previously undergone cardiac surgery including surgical LAA closure and who could be potential candidates for discontinued OAC.
  • to investigate whether different methods of surgical LAA closure result in different rates of sufficient closure of the LAA
  • to investigate the HRQOL before and after discontinuing OAC and to compare the HRQOL with and without OAC

Project group

  • Ivy Modrau, MD, dr.med, Department of Cardiothoracic and Vascular Surgery, AUH
  • Kristina Gosvig, MD, Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark
  • Lars Peter Schødt Riber, MD, PhD, DMSc, Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark

Funding

Danmarks Frie Forskningsfond.

Status

Inclusion ongoing

Project period

Start: 1 February 2024
End: 31 December 2028

Contact

Principal investigator