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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Undergoing 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.
Time frame: 6 months post-procedure.
Device success rate
The proportion of subjects who correctly deployed and implanted the device in the appropriate location
Time frame: immediate post-procedure
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.
Time frame: 6 months post-operation
Procedural success rate
Successful left atrial appendage occlusion with no device-related complications at discharge or within 7 days post-operation (whichever comes first).
Time frame: 7 days post-operation or at discharge
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.
Time frame: 3 months post-operation, 6 months post-operation
Incidence of systemic embolism
Embolism other than stroke, such as myocardial infarction, pulmonary embolism, renal infarction, splenic infarction, limb ischemia, mesenteric ischemia, etc.
Time frame: 3 months post-operation, 6 months post-operation
Serious bleeding events
Serious bleeding refers to bleeding events of types 3-5 as defined in the Bleeding Research Consortium (BARC)
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
All-cause mortality
Refer to the definition in VARC-3, which refers to death from any cause, including cardiovascular and non-cardiovascular death.
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Incidence of Device-Related Complications
Device-related complications include device embolism, device corrosion, clinically significant device-to-surrounding structure interference, device thrombosis, device breakage, device infection/endocarditis/pericarditis, device perforation/tear, device allergy-induced cardiac tamponade, pericardial effusion requiring intervention, occluder embolism, and cardiac perforation.
Time frame: 6 Months Post-Op
Occluder Performance
Cardiac CTA or transesophageal (or chest wall) echocardiography was used to evaluate the device, including displacement, dislodgement, mitral regurgitation, residual shunt, and device-related thrombosis. The incidence of these events was calculated.
Time frame: 6 Months Post-Op
Left atrial appendage occluder complete endothelialization rate
The proportion of subjects whose cardiac CTA shows complete endothelialization of the LAAO at 3 months post-occlusion. Complete endothelialization is defined as LAA density \< 100 HU or \< 25% of left atrial (LA) density under cardiac CTA examination.
Time frame: 3 months post-operation
Device-related thrombosis (DRT) incidence
assessed using cardiac CTA. DRT appears as a low-density filling defect on the left atrial side of the device surface. A thicker (\>3 mm) and more prominent low-density defect is considered a typical manifestation of DRT.
Time frame: 3 months post-operation, 6 months post-operation
Residual Leak (PDL) Incidence
Cardiac CTA was used for assessment. A residual left atrial appendage density ≥100 HU or ≥25% of the left atrial density indicated the presence of a PDL. If TEE was used for assessment, residual shunts were classified based on color jet width as: minimal (1 mm), mild (1-3 mm), or relatively significant (3 mm). Complete closure was defined as no residual shunt greater than 5 mm on TEE examination.
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE includes perioperative complications and long-term follow-up complications. Specifically: * Perioperative complications: death, cardiac tamponade, device embolism, stroke, severe bleeding, and vascular access complications; * Long-term follow-up complications: ischemic stroke, hemorrhagic stroke, thromboembolism, device-related thrombosis, severe bleeding, and death.
Time frame: 3 months post-operation, 6 months post-operation
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