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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 306
- 主要终点
- Complete endothelialization rate of the LAA occluder
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).
- •High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following:
- •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.
- •Predicted high bleeding risk (HAS-BLED score ≥ 3).
- •Status post-Left Atrial Appendage Electrical Isolation (LAAEI).
- •Subject or legal representative understands the study purpose, is willing to cooperate with surgery and follow-up, and has signed the written Informed Consent Form (ICF).
排除标准
- •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.
- •Planned ablation or cardioversion post-procedure.
- •Intracardiac thrombus (including left/right atrium).
- •Myocardial infarction within the last 3 months.
- •History of ASD repair or PFO occluder implantation.
- •History of heart valve replacement (mechanical valve).
- •Heart transplant recipient.
- •New-onset ischemic stroke or TIA within the last 30 days.
- •Severe heart failure (NYHA Class IV).
- •Severe renal impairment: eGFR < 45 ml/min/1.73m² or on dialysis.
- •Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol.
- •Pregnant or lactating women, or those planning pregnancy within one year.
- •Life expectancy < 12 months.
- •Unable to complete 2 months of anticoagulation or 6 months of DAPT for any reason.
- •Investigator's judgment of poor compliance or inability to complete the study requirements.
研究组 & 干预措施
Treatment Group
AnchorMan® Left Atrial Appendage Occluder System Treatment
干预措施: Intra-operative application of LAAC (Procedure)
结局指标
主要结局
Complete endothelialization rate of the LAA occluder
时间窗: 6 months post-procedure.
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.
次要结局
- Device success rate(immediate post-procedure)
- Clinical success rate(6 months post-operation)
- Procedural success rate(7 days post-operation or at discharge)
- Incidence of stroke and transient ischemic attack (TIA)(3 months post-operation, 6 months post-operation)
- Incidence of systemic embolism(3 months post-operation, 6 months post-operation)
- Serious bleeding events(before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation)
- All-cause mortality(before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation)
- Incidence of Device-Related Complications(6 Months Post-Op)
- Occluder Performance(6 Months Post-Op)
- Left atrial appendage occluder complete endothelialization rate(3 months post-operation)
- Device-related thrombosis (DRT) incidence(3 months post-operation, 6 months post-operation)
- Residual Leak (PDL) Incidence(before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(3 months post-operation, 6 months post-operation)