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:
NCT00431834
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.
2. Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
* Mitral valve repair or replacement
* Aortic valve repair or replacement
* Tricuspid valve repair or replacement
* Atrial septal defect (ASD) repair
* Patent foramen ovale (PFO) closure
* Coronary artery bypass procedures
3. Greater than or equal to 18 years of age
4. Able and willing to comply with study requirements by signing a consent form
5. Must be able to take the anticoagulant warfarin (Coumadin)
Exclusion Criteria:
1. Wolff-Parkinson-White syndrome
2. NYHA Class = IV
3. Left ventricular ejection fraction ≤ 30%
4. Need for emergent cardiac surgery (i.e. cardiogenic shock)
5. Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure
6. Contraindication for anticoagulation therapy
7. Left atrial diameter \> 7.0 cm
8. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
9. Renal failure requiring dialysis or hepatic failure
10. Life expectancy of less than one year
11. Pregnancy or desire to be pregnant within 12 months of the study treatment.
12. Current diagnosis of active systemic infection
13. Documented MI 6 weeks prior to study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00431834
Study Brief:
Protocol Section:
NCT00431834