Back to resultsA Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
VytronUS Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility 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
Sites / Locations
- Na Homolce Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VytronUS Ablation System
Arm Description
Treatment with the VytronUS Ablation System.
Outcomes
Primary Outcome Measures
Device or procedure related adverse events.
Secondary Outcome Measures
Pulmonary vein isolation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01900678
Brief Title
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Official Title
VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VytronUS, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VytronUS Ablation System
Arm Type
Experimental
Arm Description
Treatment with the VytronUS Ablation System.
Intervention Type
Device
Intervention Name(s)
VytronUS Ablation System
Intervention Description
Pulmonary vein isolation.
Primary Outcome Measure Information:
Title
Device or procedure related adverse events.
Time Frame
Three months post procedure.
Secondary Outcome Measure Information:
Title
Pulmonary vein isolation.
Time Frame
Three months post procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD, PhD
Organizational Affiliation
Na Homolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Na Homolce Hospital
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
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