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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997736

Enrollment

Registered

2013-11-28

Start date

2013-11-22

Completion date

2016-06-01

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation, Catheter Ablation, Ablation Techniques

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.

Interventions

DEVICEAblation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of major complications	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026