A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMa… (NCT07396493) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
306 participantsStarted 2026-02-08
Plain-language 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.
Who can participate
Age range18 Days
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient \> 40 mmHg).
What they're measuring
1
Complete endothelialization rate of the LAA occluder