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

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ClinicalTrials.gov Identifier: NCT01997736
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Toray Industries (America), Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating the Safety and Effectiveness of the Toray Satake Balloon Thermal Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date : November 22, 2013
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ablation Device: Ablation
Other Name: Toray Satake Balloon Thermal Ablation System



Primary Outcome Measures :
  1. Occurrence of major complications [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997736


Locations
United States, Michigan
William Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States, 48073
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Sponsors and Collaborators
Toray Industries (America), Inc.
Investigators
Principal Investigator: David Haines, MD William Beaumont Hospitals

Publications:
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, 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

Responsible Party: Toray Industries (America), Inc.
ClinicalTrials.gov Identifier: NCT01997736     History of Changes
Other Study ID Numbers: Toray America 2013-001
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Toray Industries (America), Inc.:
Paroxysmal Atrial Fibrillation
Catheter Ablation
Ablation Techniques

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes