APOLLO Trial version 7.0

  • Research type

    Research Study

  • Full title

    Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation.

  • IRAS ID

    274039

  • Contact name

    Mustapha El Amrani

  • Contact email

    mustapha.elamrani@medtronic.com

  • Sponsor organisation

    Medtronic

  • Clinicaltrials.gov Identifier

    NCT03242642

  • Duration of Study in the UK

    7 years, 10 months, 1 days

  • Research summary

    The APOLLO Trial is a multi-centre, global, prospective, interventional, pre-market trial to evaluate the safety and efficacy of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System in patients with severe symptomatic mitral regurgitation. (leaking of blood backwards because the mitral valve of the heart doesn’t close properly)
    Study participants will either receive the Intrepid™ TMVR procedure or the conventional open-heart surgery with any commercially available bioprosthetic mitral surgical valve, (tissue valve).
    The study has a randomized cohort and a single-arm & MAC (Mitral Annular Calcification) cohort. The study design for these cohorts is as follows:
    a. Randomized cohort: Subjects will be randomized on 1:1 basis to either Transcatheter Mitral Valve Replacement (TMVR) with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery
    b. Single-arm & MAC cohort: Subjects not able for randomization may be enrolled through a single-arm trial. Subjects enrolled in the single-arm cohort will be assigned to Transcatheter Mitral Valve Replacement (TMVR) with the Medtronic Intrepid™ TMVR System.
    The randomized, single arm and MAC cohort have all separate primary objectives and endpoints, please refer to the CIP for more details.
    Follow-up is anticipated for a minimum of five years. Each site will have at a minimum of two Co- Principal Investigators (PI), one who is an interventional cardiologist, and one who is a cardio(thoracic) surgeon. The Co-PIs have overall responsibility for the conduct of the trial at the site.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    20/LO/0041

  • Date of REC Opinion

    4 May 2020

  • REC opinion

    Further Information Favourable Opinion