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