VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Primary Safety: Incidence of early-onset serious adverse events
Timeframe: 7 days or discharge, whichever is sooner
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Timeframe: 12 months