Decision: Favourable

Decisions Table

Study Title:

LANDMARK Trial: A prospective, multinational, multicentre, open-label, randomized, noninferiority trial to compare safety and effectiveness of Meril’s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards’ Sapien THV series and Medtronic’s Evolut THV series) in patients with severe symptomatic native aortic valve stenosis.

  • NREC Code:

    22-NREC-MD-006

  • Decision:

    Favourable

  • Meeting Date:

    16/03/2022

  • Study Type:

    MD application

  • Principal Investigator:

    Dr Darren Mylotte

  • PI Institution:

    Galway University Hospital

  • Sponsor:

    Meril Life Sciences Pvt. Ltd

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