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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03437356
Eligibility Criteria:
Inclusion Criteria:
1. Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode ≥7 days (ESC 2016 guidelines).
2. Before PVI, there was at least one episode of persistent AF in the last year.
3. Signed Patient Informed Consent Form.
4. Age 18 years or older.
5. Able and willing to comply with all follow-up testing and requirements.
Exclusion Criteria:
1. Patients not willing or not suited to take any class IC or III ADT.
2. Any prior AF episode ≥12 months, or any recurrence of AF \<3 days after cardioversion.
3. Presence of structural heart disease on echo criteria:
severe valvular heart disease; LA diameter \>50mm; LV ejection fraction \<35% (except if suspected tachycardiomyopathy); septal diameter \>15mm
4. BMI \>35
5. Recent (\<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
6. Active illness or systemic infection or sepsis
7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
8. Awaiting cardiac transplantation or other cardiac surgery
9. Documented left atrial thrombus or atrial myxoma on imaging
10. History of blood clotting or bleeding abnormalities
11. Enrollment in any other study evaluating another device or drug
12. Women with childbearing potential
13. Life expectancy less than 12 months
14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03437356
Study Brief:
Protocol Section:
NCT03437356