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
  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
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 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 July 31, 2014