Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Inclusion Criteria: * Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation * ≥2 Symptomatic atrial fibrillation episodes * At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND * At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation * No episode \>7 days * Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug * Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization * Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits Exclusion Criteria: * Left atrium ≥50 mm * Chronically used amiodarone in the 3 months prior to enrollment * Previous left atrial ablation or surgical treatment for atrial fibrillation * Left ventricular ejection fraction (LVEF) \<35 % * New York Heart Association (NYHA) Class III or IV heart failure * History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment * Multiple other exclusion criteria to establish overall good health and likely study compliance