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Updated: May 21, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Different antithrombotic strategies after left atrial appendage closure with the LACbes occluder: protocol of the
Tiantian Zhang1, Jing Zhou1, Kandi Zhang1
1Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China.
Insights
This study compares dual antiplatelet therapy (DAPT) with direct oral anticoagulants (DOACs) after left atrial appendage closure (LAAC). Findings will guide optimal antithrombotic strategies post-LAAC to reduce thrombosis and bleeding risks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Thrombosis Research
Background:
- Left atrial appendage closure (LAAC) is an alternative to anticoagulation for stroke prevention in non-valvular atrial fibrillation (NVAF).
- Optimal antithrombotic therapy following LAAC remains under investigation.
- Device-related thrombosis and bleeding are key concerns after LAAC.
Purpose of the Study:
- To evaluate and compare the safety and efficacy of dual antiplatelet therapy (DAPT) versus direct oral anticoagulants (DOACs) after LAAC.
- To investigate the incidence of device-related thrombosis, clinical thrombotic events, and bleeding complications.
- To determine the optimal antithrombotic strategy post-LAAC with the LACbes occluder.
Main Methods:
- Prospective, randomised, controlled, multicentre clinical trial.
- Enrolment of 296 subjects with NVAF undergoing successful LAAC with the LACbes occluder.
- Randomisation to DAPT (aspirin and ticagrelor) or DOAC (rivaroxaban) with 12-month follow-up.
Main Results:
- Data collection includes device-related thrombosis, thrombotic events, bleeding, and adverse events.
- Follow-up at 3, 6, and 12 months post-procedure.
- Analysis will compare outcomes between the DAPT and DOAC groups.
Conclusions:
- The study aims to provide evidence for selecting the best antithrombotic regimen after LAAC.
- Findings will inform clinical practice guidelines for managing patients post-LAAC.
- This research will contribute to improving patient outcomes and reducing complications after LAAC.
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.
