Trials / Completed
CompletedNCT01997736
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Toray Industries (America), Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ablation |
Timeline
- Start date
- 2013-11-22
- Primary completion
- 2015-09-15
- Completion
- 2016-06-01
- First posted
- 2013-11-28
- Last updated
- 2019-09-06
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01997736. Inclusion in this directory is not an endorsement.