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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major complications | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Haines, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital, Royal Oak | Royal Oak | Michigan | 48073 | United States | ||
| Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12875422 | Background | 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. | |
| Background | 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. | ||
| 19808472 |
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| New York |
| New York |
| 10029 |
| United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Background |
| 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. |
| Background | 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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