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

NCT07396493 | Not Yet Recruiting

• 2 other identifiers: AM-PM-0225SF1902201
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF); High Risk of Stroke

Keywords

Non-valvular atrial fibrillation (NVAF); high risk of stroke.; Left Atrial Appendage Occluder System

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months post-procedure.

Secondary Outcomes (13)

• 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

Other Outcomes (1)

• Serum inflammatory markers

  preoperative, 24 hours postoperative, 1 week postoperative/before discharge (whichever comes first), 1 month postoperative, 3 months postoperative, 6 months postoperative

Study Arms (1)

Treatment Group

EXPERIMENTAL

AnchorMan® Left Atrial Appendage Occluder System Treatment

Procedure: Intra-operative application of LAAC

Interventions

Intra-operative application of LAAC PROCEDURE

Undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.

Treatment Group

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Ruijin Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Zhoupu Hospital, Pudong New Area, Shanghai, China: collaborator
• Changhai Hospital: collaborator

Central Study Contacts

wenzhi pan

CONTACT

0755-1234567; peden@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 9, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share