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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04239534
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years and \< 80 years at time of enrollment consent.
2. Left atrium ≤ 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view) or equivalent test.
3. Refractory or intolerant to at least one AAD (class I and/or III).
4. Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines.
5. Provided written informed consent.
Exclusion Criteria:
1. Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure.
2. Left ventricular ejection fraction \< 40%.
3. Pregnant or planning to become pregnant during study.
4. Co-morbid medical conditions that limit one-year life expectancy.
5. Previous cardiac surgery.
6. History of pericarditis.
7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA.
8. Patients who have active infection or sepsis.
9. Patients with esophageal ulcers strictures and varices.
10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40).
11. Patients who are contraindicated for anticoagulants such as heparin and coumadin.
12. Patients who are being treated for ventricular arrhythmias.
13. Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias).
14. Patients with existing ICDs.
15. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
16. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
17. Patient has presence of thrombus in the left atrium determined by intraoperative TEE.
18. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins \>50 % stenosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04239534
Study Brief:
Protocol Section:
NCT04239534