Phase
Condition
Chest Pain
Arrhythmia
Atrial Fibrillation
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is greater than or equal to 18 years of age
Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESCGuidelines
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for oneor more of the following:
Mitral valve repair or replacement
Aortic valve repair or replacement
Tricuspid valve repair or replacement
Coronary Artery Bypass procedures
Subject's Left Ventricular Ejection Fraction ≥ 30%
Subject is able and willing to provide written informed consent and comply with studyrequirements
Subject has life expectancy of at least 1 year
Exclusion
Exclusion Criteria:
Patients with longstanding and continuous AF in which cardioversion has failed or hasnot been attempted
Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgicalMaze procedure
Wolff-Parkinson-White syndrome
Prior cardiac surgery (Redo)
Class IV NYHA heart failure symptoms
Prior history of cerebrovascular accidents within 6 months or at any time if there isresidual neurological deficit
Documented MI within 6 weeks prior to study enrollment
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Known carotid artery stenosis greater than 80%
LA size greater than or equal to 8 cm
Current diagnosis of active systemic infection
Severe peripheral arterial occlusive disease defined as claudication with minimalexertion
Pregnancy or desire to get pregnant within 12-months of the study enrollment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Therapy resulting in compromised tissue integrity including: thoracic radiation,chemotherapy, long term treatment with oral or injected steroids, or known connectivetissue disorders