NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency,
acute safety, and effectiveness at one year) associated with use of the NAVISTAR®
THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent
symptomatic paroxysmal atrial fibrillation.

Inclusion Criteria:

- Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation

- Age 18 years or older

- Patients must be able and willing to provide written informed consent to participate
in the study

Exclusion Criteria:

- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause

- Previous ablation for atrial fibrillation

- Episodes of atrial fibrillation that last longer than 30 days and are terminated via
cardioversion

- Uncontrolled heart failure, or NYHA Class III or IV heart failure

- Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram

- Contraindication to anticoagulation

- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous
coronary intervention within the past 3 months

- Awaiting cardiac transplantation

- Heart disease in which corrective surgery is anticipated within 6 months

- Enrollment in investigational drug, biologic or device study

- Subjects unwilling to comply with protocol or follow-up requirements

- Patients who are pregnant