- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01900678
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
June 26, 2015 updated by: VytronUS, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Prague, Czech Republic
- Na Homolce Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VytronUS Ablation System
Treatment with the VytronUS Ablation System.
|
Pulmonary vein isolation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device or procedure related adverse events.
Time Frame: Three months post procedure.
|
Three months post procedure.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulmonary vein isolation.
Time Frame: Three months post procedure.
|
Three months post procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
July 9, 2013
First Submitted That Met QC Criteria
July 11, 2013
First Posted (Estimate)
July 16, 2013
Study Record Updates
Last Update Posted (Estimate)
June 29, 2015
Last Update Submitted That Met QC Criteria
June 26, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLIC-USA
- CIV-13-04-010581 (Registry Identifier: EUDAMED)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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