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.
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on Catheter and Surgical Ablation for Atrial Fibrillation. Eligible patients will receive treatment with the VAS including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins. Up to 100 patients will be enrolled at up to 10 sites in Europe (EU) and in the United States (US).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Catheter Ablation for Paroxysmal Atrial Fibrillation
Na Homolce
Prague, Czechia
RECRUITINGPrimary Safety: Incidence of early-onset serious adverse events
Incidence of early-onset serious adverse events
Time frame: 7 days or discharge, whichever is sooner
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Acute success and chronic freedom from AF, AFL or AT
Time frame: 12 months
Secondary Safety: All serious adverse events
All serious adverse events
Time frame: 12 months
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