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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01900678
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: VytronUS Ablation System

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Study Start Date : June 2013
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: VytronUS Ablation System
Treatment with the VytronUS Ablation System.
Device: VytronUS Ablation System
Pulmonary vein isolation.

Outcome Measures

Primary Outcome Measures :
  1. Device or procedure related adverse events. [ Time Frame: Three months post procedure. ]

Secondary Outcome Measures :
  1. Pulmonary vein isolation. [ Time Frame: Three months post procedure. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900678

Czech Republic
Na Homolce Hospital
Prague, Czech Republic
Sponsors and Collaborators
VytronUS, Inc.
Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital
More Information

Responsible Party: VytronUS, Inc.
ClinicalTrials.gov Identifier: NCT01900678     History of Changes
Other Study ID Numbers: VLIC-USA
CIV-13-04-010581 ( Registry Identifier: EUDAMED )
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes