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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01558635
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines
* Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
* Patients should be older than or equal to 18 years of age
Exclusion Criteria:
* Atrioventricular reentrant tachycardia (AVRT)
* NYHA Class = IV
* Left ejection fraction of ≤ 30%
* Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
* Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure
* Contraindication for anticoagulation therapy
* Left atrial diameter \> 7.0 cm
* Preoperative need for intra-aortic balloon pump or intravenous inotropes
* Renal failure requiring dialysis or hepatic failure
* Life expectancy of less than one year
* Pregnancy or desire to be pregnant within 12 months of the study treatment
* Current diagnosis of active systemic infection
* Documented MI 6 weeks prior to study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01558635
Study Brief:
Protocol Section:
NCT01558635