Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Toray Industries (America), Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
