NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Atrial fibrillation ablation
Intervention description: Radiofrequency ablation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this registry is to provide additional corroborative short-term safety and
      long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters
      in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).
    

Eligibility criteria:

        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.