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 range
18 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete endothelialization rate of the LAA occluder
. 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).
. Left ventricular ejection fraction (LVEF) \< 30%.
. Complex LAA anatomy unsuitable for LAAO implantation.
. Pericardial effusion \> 10mm.
. Planned ablation or cardioversion post-procedure.