CClinicalTrials.gg
CompletedNCT01900678Updated Jun 29, 2015

A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

An interventional study of VytronUS Ablation System in Paroxysmal Atrial Fibrillation, sponsored by VytronUS, Inc.. Completed at 1 site in Czech Republic. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-29.

Sponsored by VytronUS, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 7 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

VytronUS, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 to 70 years old.
  • Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.

Exclusion criteria

Exclusion Criteria:

  • Prior pulmonary vein isolation
  • Presence of intracardiac thrombus
  • Indication of inaccessible pulmonary or cardiac anatomy
  • Myocardial infarction, PCI, or cardiac surgery in prior three months
  • Moderate to severe valvular disease or prior valve replacement
  • NYHA Class IV
  • LVEF \< 40%
  • Previous stroke or TIA
  • Serum creatinine > 2.5mg/dL or allergy to intravenous contrast agents
  • Existing bleeding diathesis or history of complications with anticoagulation therapy
  • Women who are nursing, pregnant, or trying to become pregnant
  • Subjects unwilling or unable to provide consent
  • Participation in a drug or device trial that would prevent completion of required study procedures
  • Active implantable devices
  • Major organ system disease
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    VytronUS Ablation System

    Treatment with the VytronUS Ablation System.

    Device: VytronUS Ablation System

Interventions

  • DeviceVytronUS Ablation System

    Pulmonary vein isolation.

06

What researchers measure

Primary outcomes

  1. Device or procedure related adverse events.

    Time frame: Three months post procedure.

Secondary outcomes

  1. Pulmonary vein isolation.

    Time frame: Three months post procedure.

07

Study locations

1 site
  • Na Homolce Hospital
    Prague, Czech Republic
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01900678
Lead sponsor
VytronUS, Inc.
Responsible party
Sponsor
First posted
Jul 16, 2013
Start date
Jun 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jun 29, 2015

Study contacts

Petr Neuzil, MD, PhD
principal investigator · Na Homolce Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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