Clinical trial NCT01997736: 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
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Paroxysmal Atrial Fibrillation
Catheter Ablation
Ablation Techniques
Lead sponsor: Toray Industries (America), Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of major complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital, Royal Oak
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
Study officials:
affiliation: William Beaumont Hospitals
name: David Haines, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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