Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques
Eligibility 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
Sites / Locations
- William Beaumont Hospital, Royal Oak
- Mount Sinai Hospital
- Medical University of South Carolina (MUSC)
- Texas Cardiac Arrhythmia Research Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ablation
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of major complications
Secondary Outcome Measures
Full Information
NCT ID
NCT01997736
First Posted
November 8, 2013
Last Updated
September 3, 2019
Sponsor
Toray Industries (America), Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01997736
Brief Title
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 22, 2013 (Actual)
Primary Completion Date
September 15, 2015 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries (America), Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ablation
Other Intervention Name(s)
Toray Satake Balloon Thermal Ablation System
Primary Outcome Measure Information:
Title
Occurrence of major complications
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Haines, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12875422
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19808472
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
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Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
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