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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT00734058
Eligibility Criteria:
Inclusion Criteria:
* Age at least 18 years
* Documented long term persistent atrial fibrillation (also known as permanent AF).of at least 3 months duration. Persistent AF is defined as AF which is sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion. Long term persistent AF is defined as continuous AF of greater than three months duration.
* Concomitant indication for open heart surgery for at least one 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 procedure
* Be able to take anticoagulation therapy (Warfarin / Coumadin®)
* Be able to fulfill study requirements
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
Exclusion Criteria:
* Life expectancy \< 1 year
* NYHA class = IV
* Left ventricular ejection fraction (LVEF) measurement \<30%
* Left atrial diameter \> 7.5 cm
* Wolff-Parkinson-White (WPW) Syndrome
* Pregnancy or desire to be pregnant within 1 year of the study treatment
* Myocardial infarction within the previous 6 weeks
* Presence of a previously implanted device (valve, CS leads, or ICD)
* Known allergy, contraindication, or inability to comply with warfarin (Coumadin®) or heparin therapy
* Known allergy or contraindication to complying with anti-arrhythmic (Class IA, IC, III) therapy
* Previous thoracic procedure resulting in sternal opening and/or pericardial opening (e.g., CABG, valve replacement or repair)
* Current diagnosis of active endocarditis, local or systemic infection
* Renal failure requiring dialysis or hepatic failure
* Emergent cardiac surgery (cardiogenic shock)
* Preoperative need for intra-aortic balloon pump, IV inotropes or vasoactive agents
* Currently participating in another clinical research study
* Cerebral vascular accident or transient ischemic attack within previous 180 days or at any time with a documented residual neurological deficit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00734058
Study Brief:
Protocol Section:
NCT00734058