A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke

Endothelialization within the left atrial appendage represents a core biological process following transcatheter left atrial appendage closure (LAAC). Advances in this field directly influence the optimization of postoperative anticoagulation strategies and the control of device related thrombosis (DRT) risks.

This multicenter, prospective, single-arm study primarily investigates the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occlusion Device using cardiac CTA following left atrial appendage occlusion. It plans to enroll 306 non-valvular atrial fibrillation patients undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.

The device used in this study is the approved AnchorMane® Left Atrial Appendage Occlusion System, which is routinely employed in clinical practice.

What is required of me if I participate in the study?

If you decide to participate in this study, you will be enrolled after signing the informed consent form with full understanding. Participation in this trial requires your cooperation with the study physician to complete the following examinations or procedures :

* Baseline Visit (within 7 days pre-op): Collection of routine medical history, demographic data, physical examination,vital signs, modified Rankin Scale (mRS) score (if applicable), CHA2DS2,-VASc score.HAS-BLED score, NYHA functional class, electrocardiogram (EcG), laboratory tests(complete blood count, urinalysis, blood chemistry, coagulation profile, blood/urine pregnancy testif indicated, serum inflammatory markers),transesophageal echocardiography(TEE), and transthoracic echocardiography (TTE). * Baseline Visit (Intra-operative): Vital signs, serum inflammatory markers, left atrial angiography, surgical records, medication records. Collect and document endpoint events and other adverse events. * Discharge/Post-op 7-day Visit: Collect vital signs, modified Rankin Scale (mRS)score (if applicable), NYHA functional class, transthoracic echocardiogram (TTE), and laboratory test results (complete blood count, urinalysis, blood biochemistry, coagulation function, serum inflammatory markers)Complete medication records and collect/record for routine clinical care.information on endpoint events and other adverse events. * 1-month Follow-up (±7 days): Collect results from routine diagnostic procedures including cardiac ultrasound (if applicable), cardiac CTA (if applicable), and laboratory tests.Complete documentation of medication history, endpoint events, and other adverse event information. * 3-month Follow-up (±15 days): Complete and collect your routine clinical vital signs, cardiac ultrasound (if applicable), cardiac CTA, and serum inflammatory marker test results.Complete medication records, endpoint event documentation, and other adverse event records. * 6-month Follow-up (±30 days): Complete and collect results of routine clinical examinations including vital signs, cardiac ultrasound, cardiac CTA, and serum inflammatory markers. Complete medication records, endpoint event documentation, and other adverse event records. * Note: Laboratory tests included in the study comprise: Complete blood count : Collect hemoglobin, red blood cell, white blood cell, and platelet counts; Urinalysis: Collect urine red blood cells, urine white blood cells, urine protein, and urine glucose levels. Blood Biochemistry: Preoperative testing for total cholesterol, triglycerides,LDL cholesterol, HDl cholesterol, Creatinine, BUN, fasting blood glucose, albumin, ALT,AST; Pre-discharge Creatinine, alanine aminotransferase (ALT)，aspartatetests: aminotransferase (AsT). Coagulation function tests: Prothrombin time (PT), Prothrombintime international normalized ratio (INR), Activated partial thromboplastin time (APTT),Thrombin time (TT). Approximately 3 ml of blood will be drawn for each blood test, and approximately 3 ml of urine will be collected for each urine test. Your blood and urine samples will be used solely for routine hospital analysis and will not be sent externally.Remaining samples will be destroyed according to standard hospital protocols. During the study, we will need to collect your imaging data. This data will undergo de-identification and will be used exclusively for this research.

• Device success rate [Срок оценки: immediate post-procedure]
• Clinical success rate [Срок оценки: 6 months post-operation]
• Procedural success rate [Срок оценки: 7 days post-operation or at discharge]
• Incidence of stroke and transient ischemic attack (TIA) [Срок оценки: 3 months post-operation, 6 months post-operation]
• Incidence of systemic embolism [Срок оценки: 3 months post-operation, 6 months post-operation]
• Serious bleeding events [Срок оценки: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation]
• All-cause mortality [Срок оценки: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation]
• Incidence of Device-Related Complications [Срок оценки: 6 Months Post-Op]
• Occluder Performance [Срок оценки: 6 Months Post-Op]
• Left atrial appendage occluder complete endothelialization rate [Срок оценки: 3 months post-operation]
• Device-related thrombosis (DRT) incidence [Срок оценки: 3 months post-operation, 6 months post-operation]
• Residual Leak (PDL) Incidence [Срок оценки: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation]