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Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation — VALUE  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study

Clinical Trial 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.

Clinical Trial Description

Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker, calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure description below). Acute post-ablation confirmation of PV electrical isolation will be evaluated via standard mapping techniques. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03639597
Study type Interventional
Source VytronUS, Inc.
Contact
Status Completed
Phase N/A
Start date January 18, 2016
Completion date December 2018
View Details
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