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

This study has been completed.
Information provided by (Responsible Party):
VytronUS, Inc. Identifier:
First received: July 9, 2013
Last updated: June 26, 2015
Last verified: June 2015
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 Intervention
Paroxysmal Atrial Fibrillation
Device: VytronUS Ablation System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by VytronUS, Inc.:

Primary Outcome Measures:
  • Device or procedure related adverse events. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary vein isolation. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: June 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VytronUS Ablation System
Treatment with the VytronUS Ablation System.
Device: VytronUS Ablation System
Pulmonary vein isolation.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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. Identifier: NCT01900678     History of Changes
Other Study ID Numbers: VLIC-USA  CIV-13-04-010581 
Study First Received: July 9, 2013
Last Updated: June 26, 2015
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 28, 2016