Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07396493
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).
2. High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following:
1. Documented history of bleeding (\> 6 months ago) or bleeding tendency (e.g., gingival, nasal, GI, urinary tract, cerebral hemorrhage).
2. Intolerance or unwillingness to undergo long-term anticoagulation therapy.
3. Recurrent stroke or embolic events despite standardized anticoagulation.
4. Predicted high bleeding risk (HAS-BLED score ≥ 3).
5. Status post-Left Atrial Appendage Electrical Isolation (LAAEI).
3. 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:
1. Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient \> 40 mmHg).
2. Left ventricular ejection fraction (LVEF) \< 30%.
3. Complex LAA anatomy unsuitable for LAAO implantation.
4. Pericardial effusion \> 10mm.
5. Planned ablation or cardioversion post-procedure.
6. Intracardiac thrombus (including left/right atrium).
7. Myocardial infarction within the last 3 months.
8. History of ASD repair or PFO occluder implantation.
9. History of heart valve replacement (mechanical valve).
10. Heart transplant recipient.
11. New-onset ischemic stroke or TIA within the last 30 days.
12. Severe heart failure (NYHA Class IV).
13. Severe renal impairment: eGFR \< 45 ml/min/1.73m² or on dialysis.
14. Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol.
15. Pregnant or lactating women, or those planning pregnancy within one year.
16. Life expectancy \< 12 months.
17. Unable to complete 2 months of anticoagulation or 6 months of DAPT for any reason.
18. Investigator's judgment of poor compliance or inability to complete the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Days
Study:
NCT07396493
Study Brief:
Protocol Section:
NCT07396493