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

This study is currently recruiting participants.
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
  Purpose

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 ]

Estimated Enrollment: 15
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01900678

Contacts
Contact: Christopher Schneider 408-730-1333 cschneider@vytronus.com

Locations
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic
Contact: Libor Machalek    +420 2 257 252 144    libor.machalek@homolka.cz   
Principal Investigator: Petr Neuzil, MD, PhD         
Principal Investigator: Vivek Reddy, MD         
Sponsors and Collaborators
VytronUS, Inc.
Investigators
Principal Investigator: Petr Neuzil, MD, PhD Na Homolce Hospital
  More Information

No publications provided

Responsible Party: VytronUS, Inc.
ClinicalTrials.gov Identifier: NCT01900678     History of Changes
Other Study ID Numbers: VLIC-USA, CIV-13-04-010581
Study First Received: July 9, 2013
Last Updated: July 11, 2013
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on April 15, 2014