NCT07396493Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 8 Feb 2026
- Primary completion date
- 12 Jun 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT07396493
What you commit to
- Study type: Interventional
- Planned participants: 306
- From 8 Feb 2026 to the primary completion date, 12 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient \> 40 mmHg).
- 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).
- Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol.
Lab values
- Left ventricular ejection fraction (LVEF) \< 30%.
- Severe renal impairment: eGFR \< 45 ml/min/1.73m² or on dialysis.
Other
- Complex LAA anatomy unsuitable for LAAO implantation.
- Pericardial effusion \> 10mm.
- Planned ablation or cardioversion post-procedure.
- Intracardiac thrombus (including left/right atrium).
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 days to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.