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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT04377594
Eligibility Criteria:
Inclusion Criteria:
1. ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition
2. Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation.
3. Suitable candidate for catheter ablation.
4. Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs
5. Age ≥18 years.
Exclusion Criteria:
1. LA dimension \>55 mm as determined by an echocardiography within the previous year
2. Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
3. Severe aortic or mitral valvular heart disease using the ESC guidelines
4. Congenital heart disease
5. Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation
6. Medical condition likely to limit survival to \< 1 year
7. New York Heart Association (NYHA) class IV heart failure symptoms
8. Contraindication to oral anticoagulation
9. Renal failure requiring dialysis
10. AF due to reversible cause
11. Pregnant and fertile women without anticonception
12. History of non-compliance to medical therapy
13. Unable or unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04377594
Study Brief:
Protocol Section:
NCT04377594