Slow enrollment

The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).

Inclusion Criteria:

• Patient age >= 18 years
• Documented permanent AF (for at least three months)
• Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
• Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

• Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
• Myocardial infarction within the previous 6 weeks
• Documented history of pulmonary vein stenosis
• Previous ablation attempt for AF
• Previous thoracic procedures
• Left atrial size > 7.0 cm
• Left ventricular ejection fraction < 30%
• Presence of left atrial or left atrial appendage thrombi
• Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
• Known allergy or contraindication to warfarin therapy
• Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
• Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
• Geographically remote or unable to return for follow-up examinations
• Pregnant or planning to become pregnant during the study
• Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study