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