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

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.

NCT Number	NCT07396493
Lead Sponsor	Shanghai Zhongshan Hospital Collaborators: Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhoupu Hospital, Pudong New Area, Shanghai, China, Changhai Hospital
Conditions	Non-valvular Atrial Fibrillation (NVAF), High Risk of Stroke
Enrollment	306 participants
Start Date	2026-02-08
Primary Completion	2027-06-12 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-09