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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by VytronUS, Inc.
Sponsor:
Information provided by (Responsible Party):
VytronUS, Inc.
ClinicalTrials.gov Identifier:
NCT01900678
First received: July 9, 2013
Last updated: July 11, 2013
Last verified: July 2013

July 9, 2013
July 11, 2013
June 2013
January 2014   (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.
 
Recruiting
15
October 2014
January 2014   (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: Christopher Schneider 408-730-1333 cschneider@vytronus.com
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.
July 2013

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