A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
NCT ID: NCT01900678
Last Updated: 2015-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2013-06-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VytronUS Ablation System
Treatment with the VytronUS Ablation System.
VytronUS Ablation System
Pulmonary vein isolation.
Interventions
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VytronUS Ablation System
Pulmonary vein isolation.
Eligibility Criteria
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Inclusion Criteria
* Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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VytronUS, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Petr Neuzil, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Na Homolce Hospital
Locations
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Na Homolce Hospital
Prague, , Czechia
Countries
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Other Identifiers
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CIV-13-04-010581
Identifier Type: REGISTRY
Identifier Source: secondary_id
VLIC-USA
Identifier Type: -
Identifier Source: org_study_id
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