Percutaneous Arteriovenous Anastomosis in recurrent Vasovagal Syncope

  • Research type

    Research Study

  • Full title

    Percutaneous Arteriovenous Anastomosis in recurrent Vasovagal Syncope: a double blind randomised placebo-controlled study

  • IRAS ID

    257149

  • Contact name

    Neil Sulke

  • Contact email

    neil.sulke@nhs.net

  • Sponsor organisation

    VESS Medical INC

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT00000000

  • Duration of Study in the UK

    1 years, 7 months, 1 days

  • Research summary

    Vasodepressor syncope is the commonest form of fainting which affects 1 in 2 persons in their lifetime. There is currently no cure and most treatments given including conservative measures such as physical manoeuvres or medications such as Fludrocortisone have not been shown to be effective.

    The Coupler device creates a communication between the artery and vein in the groin. It was originally developed for the treatment of advanced chronic obstructive pulmonary disease and then used in the treatment of patients with resistant high blood pressure.

    This study will now test this device in patients who have vasodepressor syncope / simple faints.This may be the first device to cure vasodepressor syncope or simple feints.

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    19/LO/1168

  • Date of REC Opinion

    15 Jul 2019

  • REC opinion

    Unfavourable Opinion