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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT06578793
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 80 years
2. For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two episodes of persistent atrial fibrillation in the past 6 months even after rhythm conversion; poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
3. Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
4. Patient willing to receive medication or surgical treatment
5. Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
6. Capable of completing a 6-minute walk test
7. For women of childbearing potential, a negative pregnancy test result is required
Exclusion Criteria:
1. Presence of thrombus in the left atrium
2. Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
3. Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
4. Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
5. Currently suffering from valvular heart disease requiring surgical intervention
6. Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
7. History of atrioventricular node ablation
8. Liver failure
9. Renal failure requiring dialysis
10. Contraindicated use of appropriate anticoagulation therapy
11. Participation in other experimental drug or device studies
12. Severe pulmonary disease
13. Previous catheter ablation for atrial fibrillation in the left atrium
14. Documented thromboembolic event within the past 90 days
15. Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06578793
Study Brief:
Protocol Section:
NCT06578793