Status:
COMPLETED
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Lead Sponsor:
VytronUS, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Age 18 to 70 years old.
- Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01900678
Start Date
June 1 2013
End Date
January 1 2015
Last Update
June 29 2015
Active Locations (1)
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1
Na Homolce Hospital
Prague, Czechia