Decision: Favourable
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