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



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:November 2013

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

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.


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
We found this trial at
4
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Austin, TX
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Charleston, South Carolina 29425
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1 Gustave L. Levy Pl
New York, New York 10029
(212) 241-6500
The Mount Sinai Hospital Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Royal Oak, MI
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