Completed

VALUEClinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study

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What is being tested

VytronUS Ablation System

Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 75 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2016
See protocol details

Summary

Principal SponsorVytronUS, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 18, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleClinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study
NCT03639597
Principal SponsorVytronUS, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
Age between 18 and 75 years
History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by: Episodes of AF i.≥2 recurrent AF episodes of more than 30 seconds' duration that self-terminate and lasting no more than 7 continuous days or ii.Episodes of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion count as a paroxysmal atrial fibrillation episode b.At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year
Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
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22 exclusion criteria prevent from participating
Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)
AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
Prior LA ablation or surgery
Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
VytronUS Ablation System

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Na Homolce

Prague, CzechiaOpen Na Homolce in Google Maps
CompletedOne Study Center