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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07445360
Eligibility Criteria:
Inclusion Criteria:
1. Subjects≥ 18 years old and ≤ 75 years old;
2. the subject was diagnosed with persistent atrial fibrillation (duration of ≥6 months and ≤ 3 years);
3. Able to understand the purpose of the trial, voluntarily participate in this study, the subject or his legal representative signed the informed consent form, and was willing to complete the follow-up according to the requirements of the protocol.
Exclusion Criteria:
1. Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;
2. atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;
3. Left atrial or left atrial appendage thrombus (confirmed by esophageal ultrasound or CT examination);
4. Patients with pulmonary vein stenosis or pulmonary vein stents implanted;
5. Have had atrial septal repair or atrial myxoma;
6. Severe structural heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease);
7. Cardiac ultrasound showed that the diameter of the left atrium was ≥50mm
8. New York College of Cardiology (NYHA) cardiac function grades III and IV; LVEF\<40%；
9. Those with cerebrovascular diseases (including stroke, transient ischemic attack) in the past 3 months;
10. Those who have had cardiovascular events in the past 3 months (including acute myocardial infarction, coronary intervention or heart bypass);
11. surgery, prosthetic valve replacement or repair, atrial or ventriculotomy;
12. Those with acute or severe systemic infection;
13. Combined with severe liver and kidney insufficiency (AST or ALT≥ 3 times the upper limit of normal; SCr\>3.5mg/dl or Ccr\<30ml/min);
14. Those with obvious bleeding tendency and hematologic diseases, or contraindications to anticoagulation;
15. Patients with malignant tumors and end-stage diseases with a life expectancy of \< 12 months; After chemotherapy or radiotherapy for malignant tumors;
16. The subject is a female who is pregnant or lactating or cannot use contraception during the trial;
17. The subject has participated in clinical trials of other drugs or devices during the same period;
18. Abnormalities or diseases that, in the opinion of the investigator, should be excluded from the scope of enrollment in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07445360
Study Brief:
Protocol Section:
NCT07445360