NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

This registry is a prospective, multi-center, non-randomized post approval evaluation
comprised of two (2) registry arms with independent hypotheses. The registry arms are defined
as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation
procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation
ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be
considered for this post approval registry. This registry will be conducted at up to 40
centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for
commercial distribution under PMA #P030031/S11.

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

- Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF
episodes in the six (6) months prior to enrollment and one AF episode documented
within the one (1) year prior to enrollment. Documentation may include
electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or
telemetry strip.

- Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as
beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF,
or intolerable side effects.

- Age 18 years or older.

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

- Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

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

- AF episodes that last longer than 30 days and are terminated via cardioversion.

- CABG procedure within the last six (6) months.

- Awaiting cardiac transplantation or other cardiac surgery.

- Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).

- History of a documented thromboembolic event within the past one (1) year.

- Diagnosed atrial myxoma.

- Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this registry.

- Women who are pregnant (by history of menstrual period or pregnancy test if the
history is considered unreliable).

- 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 (i.e. heparin or warfarin).

- Life expectancy less than 12 months.

- Enrollment in an investigational study evaluating another device or drug.

- Presence of intramural thrombus, tumor or other abnormality that precludes catheter
introduction or manipulation.