Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
NCT ID: NCT01997736
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2013-11-22
2016-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ablation
Ablation
Interventions
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Ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
18 Years
ALL
No
Sponsors
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Toray Industries (America), Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Haines, MD
Role: PRINCIPAL_INVESTIGATOR
William Beaumont Hospitals
Locations
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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
Countries
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References
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Satake S, Tanaka K, Saito S, Tanaka S, Sohara H, Hiroe Y, Miyashita Y, Takahashi S, Murakami M, Watanabe Y. Usefulness of a new radiofrequency thermal balloon catheter for pulmonary vein isolation: a new device for treatment of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Jun;14(6):609-15. doi: 10.1046/j.1540-8167.2003.02577.x.
Sohara H, Satake S, Tanaka K, et al. Modification of electrophysiological properties of pulmonary veins and adjacent left atrial tissue by radiofrequency thermal balloon circumferential ablation around the pulmonary vein ostia: correlation with non-recurrence of atrial fibrillation. Journal of Arrhythmia 21(3):384-397, 2005.
Sohara H, Takeda H, Ueno H, Oda T, Satake S. Feasibility of the radiofrequency hot balloon catheter for isolation of the posterior left atrium and pulmonary veins for the treatment of atrial fibrillation. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):225-32. doi: 10.1161/CIRCEP.108.817205. Epub 2009 Apr 2.
Sohara H, Satake S, Takeda H, et al. Radiofrequency hot balloon catheter ablation for the treatment of atrial fibrillation: a 3-center study in Japan. Journal of Arrhythmia 29:20-27, 2013
Other Identifiers
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Toray America 2013-001
Identifier Type: -
Identifier Source: org_study_id
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