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

Starting soon · Not applicable

Conditions studied: Non-valvular Atrial Fibrillation (NVAF), High Risk of Stroke

In brief

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.

Key facts

Study ID: NCT07396493
Run by: Shanghai Zhongshan Hospital
People needed: 306
Starts: 2026-02-08
Expected to finish: 2027-12-31
Last updated by the study team: 2026-02-09

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Full record on ClinicalTrials.gov

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