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

  t.wong@rbht.nhs.uk

• Sponsor organisation

  VytronUS, Inc.

• Clinicaltrials.gov Identifier

  NCT03513029

• 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