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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Toray Industries (America), Inc.
Sponsor:
Information provided by (Responsible Party):
Toray Industries (America), Inc.
ClinicalTrials.gov Identifier:
NCT01997736
First received: November 8, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation
Device: Ablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Toray Industries (America), Inc.:

Primary Outcome Measures:
  • Occurrence of major complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ablation Device: Ablation
Other Name: Toray Satake Balloon Thermal Ablation System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997736

Locations
United States, Michigan
William Beaumont Hospital, Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: James H Wegner, BS    248-898-3123    jwegner@beaumonthospitals.com   
Principal Investigator: David Haines, MD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Betsy A. Ellsworth, MSN, ANP    212-824-8902    betsy.ellsworth@mountsinai.org   
Contact: Mindy Lopez    212-824-8925    mindy.lopez@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Debi Adams, RN, BSN    843-792-2944    adamsde@musc.edu   
Contact: Stacey Wilson, MS    843-876-5008    wilstac@musc.edu   
Principal Investigator: Marcus Wharton, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal, RN    512-458-9410    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
Sponsors and Collaborators
Toray Industries (America), Inc.
Investigators
Principal Investigator: David Haines, MD William Beaumont Hospitals
  More Information

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
Study First Received: November 8, 2013
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014