Comparing Non-Antithrombotic Therapy and Single Antiplatelet Therapy After Left Atrial Appendage Closure in Patients with High Bleeding Risk and Nonvalvular Atrial Fibrillation

What this Trial Is About

Researchers are evaluating two different approaches to antithrombotic therapy after Left Atrial Appendage Closure LAAC in people with non-valvular atrial fibrillation who have a high risk of bleeding. The study compares Non-Antithrombotic Therapy NAPT followed by oral anticoagulants OAC monotherapy for 45 days against Single Antiplatelet Therapy SAPT with aspirin. This Phase 4 trial aims to determine if the NAPT approach is not worse than SAPT over an observation period of up to 4 years, focusing on a combination of serious events including death, heart attack, stroke, embolism, and bleeding complications. Participants are randomly assigned to one of two groups the SAPT arm or the NAPT arm, with equal chance of assignment. Both groups start with oral anticoagulants for 45 days after LAAC. After this period, the SAPT group continues with low-dose aspirin, while the NAPT group does not receive further antithrombotic medication for the remainder of the study. The study includes visits at 45 days, 1 year, and 2 years after enrollment, along with telephone follow-ups up to 4 years. During their participation, subjects will undergo clinical evaluations to monitor safety and effectiveness, including imaging tests to check for device-related thrombus at specific intervals. Researchers will track major health events such as mortality, heart attacks, strokes, embolism, and bleeding incidents throughout the study. The study includes regular hospital visits, phone assessments, and ongoing observation, lasting up to 4 years per participant to thoroughly assess long-term outcomes.

Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure