Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation
NCT03639597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2019-04-24
Summary
The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Conditions
- Paroxysmal Atrial Fibrillation
Interventions
- DEVICE
-
VytronUS Ablation System
Sponsors & Collaborators
-
VytronUS, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-18
- Primary Completion
- 2017-12-31
- Completion
- 2018-12-31
Countries
- Czechia
Study Locations
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