This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development.
Study Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year.
The expected duration of participation for each participant is approximately 6 months.
Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).
Documented history of bleeding (> 6 months ago) or bleeding tendency (e.g., gingival, nasal, GI, urinary tract, cerebral hemorrhage).
Intolerance or unwillingness to undergo long-term anticoagulation therapy.
Recurrent stroke or embolic events despite standardized anticoagulation.
Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient > 40 mmHg).
Left ventricular ejection fraction (LVEF) < 30%.
Complex LAA anatomy unsuitable for LAAO implantation.
Pericardial effusion > 10mm.
Shanghai Zhongshan Hospital
Lead sponsor
Ruijin Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Zhoupu Hospital, Pudong New Area, Shanghai, China
Collaborator
Changhai Hospital
Collaborator