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.
Single group
Intra-operative application of LAAC
Procedure/SurgeryUndergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.
Complete endothelialization rate of the LAA occluder
The proportion of subjects whose cardiac CTA shows complete endothelialization of the LAAO at 6 months post-occlusion. Complete endothelialization is defined as LAA density \< 100 HU or \< 25% of left atrial (LA) density under cardiac CTA examination.
Device success rate
The proportion of subjects who correctly deployed and implanted the device in the appropriate location
Clinical success rate
The proportion of patients who do not experience ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death, or death of unknown cause after occlusion.
Procedural success rate
Successful left atrial appendage occlusion with no device-related complications at discharge or within 7 days post-operation (whichever comes first).
Incidence of stroke and transient ischemic attack (TIA)
Stroke is defined as all strokes in the Valve Research Consortium (VARC-3), specifically including ischemic stroke, hemorrhagic stroke, and undetermined stroke.
Serum inflammatory markers
Serum inflammatory markers\[18\] mainly include high-sensitivity C-reactive protein (Hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), matrix metalloproteinase-9 (MMP-9), and von Willebrand factor (vWF).
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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
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