A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Not Applicable
Completed
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: VytronUS Ablation System
- Registration Number
- NCT01900678
- Lead Sponsor
- VytronUS, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VytronUS Ablation System VytronUS Ablation System Treatment with the VytronUS Ablation System.
- Primary Outcome Measures
Name Time Method Device or procedure related adverse events. Three months post procedure.
- Secondary Outcome Measures
Name Time Method Pulmonary vein isolation. Three months post procedure.
Trial Locations
- Locations (1)
Na Homolce Hospital
🇨🇿Prague, Czech Republic