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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VytronUS, Inc.
ClinicalTrials.gov Identifier:
NCT01900678
First received: July 9, 2013
Last updated: June 26, 2015
Last verified: June 2015

July 9, 2013
June 26, 2015
June 2013
January 2015   (final data collection date for primary outcome measure)
Device or procedure related adverse events. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01900678 on ClinicalTrials.gov Archive Site
Pulmonary vein isolation. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: VytronUS Ablation System
Pulmonary vein isolation.
Experimental: VytronUS Ablation System
Treatment with the VytronUS Ablation System.
Intervention: Device: VytronUS Ablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01900678
VLIC-USA, CIV-13-04-010581
Yes
VytronUS, Inc.
VytronUS, Inc.
Not Provided
Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital
VytronUS, Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP