Different antithrombotic strategies after left atrial appendage closure with the LACbes occluder: protocol of the DAAL trial
,
Jing Zhou,
Qing He,
Yansong Li,
Wei Hu,
Junfeng Zhang,
Lei Hou,
Xiaoli Chen,
Chengxing Shen,
Tiantian Zhang,
Kandi Zhang,
Cailan Zhang,
Kan Chen,
Zhihua Han,
Zhengde Tang,
Zongqi Zhang,
Qingyong Zhang,
Guang'an Liu,
Yuan Bai,
Zhuo Shang,
Shuxin Zhang,
Jiahong Xu,
Zhongping Ning,
Xiangdong Xu,
Suxia Han,
Xintao Deng
Affiliations
University of Southampton Faculty of Medicine, Southampton, UK
Jing Zhou
data analyst
Qing He
Department of Surgical Intensive Care Unit, Sun Yat-Sen University, Guangzhou, China
Yansong Li
Geneva Foundation, Tacoma, Washington, USA
Wei Hu
Government Affairs Service Centre, Health Commission of Guangdong Province, Guangzhou, Guangdong, China
Junfeng Zhang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Lei Hou
Department of cardiology, Shanghai Songjiang District Central Hospital, Songjiang, Shanghai, China
Xiaoli Chen
Guangzhou Huanan Business College, Guangzhou, China
Chengxing Shen
Department of Cardiology, Shanghai Sixth People`s Hospital, Shanghai, Shanghai, China
Tiantian Zhang
Department of Rheumatology and Immunology, The Second Affiliated Hospital of Shenzhen University, The People’s Hospital of Baoan Shenzhen, Shenzhen, Guangdong, China
Kandi Zhang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Cailan Zhang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Kan Chen
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Zhihua Han
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Zhengde Tang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Zongqi Zhang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
Qingyong Zhang
Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China
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.
