Different antithrombotic strategies after left atrial appendage closure with the LACbes occluder: protocol of the DAAL trial.

INTRODUCTION

The purpose of this study is to evaluate the safety and efficacy of two different antithrombotic strategies, dual antiplatelet therapy (DAPT, aspirin and ticagrelor) and direct oral anticoagulant (DOAC, rivaroxaban), after left atrial appendage closure (LAAC) using the LACbes occluder.

METHODS AND ANALYSIS: This study is a prospective, randomised, controlled and multicentre clinical trial that will compare the clinical efficacy of antiplatelet and anticoagulation therapy after LAAC with the LACbes occluder. It is planned to enrol 296 subjects with non-valvular atrial fibrillation (NVAF) who complete transcatheter closure of the left atrial appendage successfully. All subjects who pass the screening process and sign informed consent forms will be randomised in a 1:1 ratio to the DAPT group (aspirin 100 mg/day and ticagrelor 90 mg two times a day) or the DOAC group (rivaroxaban 15 mg/day). Baseline data within 24 hours after the operation and follow-up information at 3, 6 and 12 months will be recorded to investigate the difference in the incidence of device-related thrombosis, clinical thrombotic events, bleeding and other adverse events.

ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee of Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (Approval number SH9H-2022-T426-1). The protocol (Version: V1, 20230105) has also been submitted and approved by the institutional ethics committee at each participating centre. Results are expected in 2025 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.

TRIAL REGISTRATION NUMBER: ChiCTR2100046712.

TRIAL REGISTRATION NAME: Different antithrombotic strategies after left atrial appendage closure with the LACbes occluder.