A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

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.

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