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

Toray Industries

Status

Completed

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01997736

Toray America 2013-001

Details and patient eligibility

About

The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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