Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

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