Sole-Therapy Treatment of Atrial Fibrillation

Inclusion Criteria

• •1. Male or female patient between 18 and 80 years of age
• •2. Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
• •* Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
• •* Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
• •* Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
• •3. Left Atrial Size \< 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
• •4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
• •5. Patient is willing and able to provide written informed consent.
• •6. Patient has a life expectancy of at least 2 years.
• •7. Patient is willing and able to attend the scheduled follow-up visits.
• •8. Weight \< 325 lbs