VITAL
Research type
Research Study
Full title
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
IRAS ID
230460
Contact name
Tom Wong
Contact email
Sponsor organisation
VytronUS, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
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).REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0967
Date of REC Opinion
17 Aug 2018
REC opinion
Further Information Favourable Opinion