Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure (SAFE-LAAC)

Description of the study: ranscatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. However, an optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC are of paramount importance as they may significantly contribute to post-procedural as well as long-term procedural safety and efficacy.
The main objective: SAFE-LAAC Trial has been designed as a comparative health effectiveness study with the following aims:

  • compare the safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer or WATCHMAN device (randomized comparison)
  • compare safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with a single antiplatelet agent (nonrandomized comparison)
National Institute of Cardiology

Protocol number:
2.52/IV/16 ID:

Project Manager/Main Investigator:
dr hab. med. Radosław Pracoń

Duration of the study: