Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

Inclusion Criteria:

• Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6)months prior to randomization, and who are selected for catheter ablation for thetreatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversionand who require PVI only for the treatment of their AF (supported by the consensusstatement2). At least one AF episode should be documented either on ECG, TTM, HM ortelemetry strip.

• Failure of at least one AAD for PAF [class I or III] as evidenced by recurrentsymptomatic PAF, or intolerable side effects due to the AAD.

• Signed Patient Informed Consent Form.

• Age 18 years or older.

• Able and willing to comply with all pre- and follow-up testing and requirements.

Exclusion Criteria:

• Longstanding persistent atrial fibrillation

• Patients with a history of any atrial flutter requiring ablation in the right atriumduring the study procedure

• Patients in whom sinus rhythm was maintained for less than 1 week after electricalcardioversion

• Previous ablation for AF

• LA size > 55 mm

• LVEF < 40% (ejection fraction)

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause

• CABG procedure within the last six (6) months

• Awaiting cardiac transplantation or other cardiac surgery

• Documented left atrial thrombus on imaging (eg, TEE)

• Diagnosed atrial myxoma

• Women who are pregnant (by history of menstrual period or pregnancy test if thehistory is considered unreliable) or breastfeeding

• Acute illness or active systemic infection or sepsis

• Unstable angina

• Uncontrolled heart failure

• Myocardial infarction within the previous two (2) months

• History of blood clotting or bleeding abnormalities

• Contraindication to anticoagulation therapy (ie. heparin or warfarin)

• Life expectancy less than 12 months

• Enrollment in any other study evaluating another device or drug

• Presence of intramural thrombus, tumor or other abnormality that precludes catheterintroduction or manipulation