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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06363604
Eligibility Criteria:
Inclusion Criteria:
1. Between 18-85 years old;
2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
3. Prepared to undergo atrial fibrillation catheter ablation;
4. Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.
Exclusion Criteria:
1. Presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months;
2. On the heart transplant list;
3. Life expectancy less than 1 year;
4. With other bleeding disorders that cannot be treated with anticoagulation therapy;
5. With left atrial thrombus;
6. Heart failure with NYHA class III-IV or LVEF\<40%;
7. With uncontrolled malignant tumor;
8. Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%);
9. History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
10. Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06363604
Study Brief:
Protocol Section:
NCT06363604