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

November 8, 2013
July 17, 2014
November 2013
September 2015   (final data collection date for primary outcome measure)
Occurrence of major complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01997736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: Ablation
Other Name: Toray Satake Balloon Thermal Ablation System
Experimental: Ablation
Intervention: Device: Ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01997736
Toray America 2013-001
Yes
Toray Industries (America), Inc.
Toray Industries (America), Inc.
Not Provided
Principal Investigator: David Haines, MD William Beaumont Hospitals
Toray Industries (America), Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP