Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
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).
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