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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04897204
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-85 years old;
2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
3. CHA2DS2-VASc score ≥ 2 points;
4. The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
5. Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Exclusion Criteria:
1. Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
2. There are plans for cardiac surgery within 90 days;
3. Stroke/transient ischemic attack occurred within 30 days;
4. Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
5. Heart failure NYHA heart function grade IV;
6. LVEF\<30%;
7. Combined with other serious diseases, the life expectancy is less than 2 years;
8. Within 6 months after cardiac revascularization or other cardiac surgery;
9. Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
10. Obviously abnormal liver and kidney function and coagulation function;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04897204
Study Brief:
Protocol Section:
NCT04897204