MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial)

  • Research type

    Research Study

  • Full title

    MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial)

  • IRAS ID

    170943

  • Contact name

    Simon Redwood

  • Contact email

    simon.redwood@gstt.nhs.uk

  • Sponsor organisation

    MVRx, Inc

  • Clinicaltrials.gov Identifier

    NCT02302872

  • Duration of Study in the UK

    4 years, 2 months, 1 days

  • Research summary

    This is a clinical study that will be lead on around 30 patients in three countries (France, Latvia and UK), suffering all from mitral regurgitation (a condition in which blood flows through the mitral valve in the incorrect direction during part of the cardiac cycle) associated with heart failure (a condittion in which the heart cannot pump enough blood to meet the body’s needs). Due to their medical condition, patients selected for the study are not suitable for standard open-heart surgery and the treatment under study (a mitral valve repair system called PS3) will be proposed to them instead. After screening patients for eligibility, if they meet requirements they will be enrolled and followed-up for 3 years with various examinations and tests. The results of examinations performed all along the study will help evaluate the safety and feasibility of the PS3 System.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    15/LO/0928

  • Date of REC Opinion

    28 Aug 2015

  • REC opinion

    Further Information Favourable Opinion