A Prospective Exploratory Clinical Observation of Two Short-term Regimens (Dual Antiplatelet or Novel Oral Anticoagulant) for Subjects With Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion by LAMax LAAC® Device
This is a prospective, single-center, randomized, exploratory clinical observation to explore the overall benefit of short-term dual antiplatelet or novel oral anticoagulant regimens after left atrial appendage (LAA) occlusion by LAMax LAAC® occluder for subjects with non-valvular atrial fibrillation (AF), which will provide a basis for subsequent research on real-world safety and efficacy of LAA closure (LAAC).
• 1\. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF);
• 2\. Subjects with LAAC indications: according to the 2023 SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Attachment Closure, transcatheter LAAC is suitable for non-valvular AF patients with high risk of thromboembolism but unsuitable for long-term use of oral anticoagulants (OACs), including the following situations:
‣ Have a much higher risk of having stroke (CHA2DS2-VASc score: male ≥ 2 points, female ≥ 3 points),
⁃ Have OAC intolerance or a much higher risk of bleeding (such as HAS-BLED score ≥ 3 points),
⁃ Have sufficient life expectancy (minimum\>1 year) and expected to improve quality of life after LAAC;
• 3\. Successful left atrial appendage occlusion with LAMax LAAC® device;
• 4\. Patients and their families fully understand the purpose of the study, voluntarily participate in the study and sign the informed consent form.