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

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997736
• Other study ID #: Toray America 2013-001
• Status: Completed
• Phase: N/A
• Start date: November 22, 2013
• Est. completion date: June 1, 2016

Study information

• Verified date: April 2018
• Source: Toray Industries (America), Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 1, 2016
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Ablation

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Mount Sinai Hospital	New York	New York
United States	William Beaumont Hospital, Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries (America), Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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

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, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of major complications		6 months