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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