Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
Duration of Study in the UK
1 years, 7 months, 31 days
In summary, extensive bench and pre-clinical testing have defined safe parameters for operation. Results from the VytronUS’ VLIC-USA and VALUE studies demonstrate that the VAS performs in a satisfactory manner. The VAS may be a valuable addition to existing technology available to treat PAF and should be studied in a larger clinical trial.
The ultimate goal of left atrial ablation is to reduce the incidence of recurrent atrial fibrillation, to reduce morbidity and mortality from AF and to improve quality of life. This study will investigate the safety and effectiveness of the VAS for catheter-based cardiac ultrasound anatomical mapping and ablation for the treatment of drug refractory, symptomatic, paroxysmal atrial fibrillation (PAF).
London - Dulwich Research Ethics Committee
Date of REC Opinion
17 Aug 2018
Further Information Favourable Opinion