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

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01997736

Run by

Toray Industries (America), Inc.

People needed

41

Starts

2013-11-22

Expected to finish

2016-06-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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
• Multiple other exclusion criteria to establish overall good health and likely study compliance

Where it is running

• William Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States
• Mount Sinai Hospital — New York, New York, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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