LANDMARK Trial

Title: A prospective, multinational, multicentre, open-label, randomised, non-inferiority 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

Study Design

This is a prospective, randomised, multinational, multi-centre, open-label non-inferiority trial to compare clinical outcomes of Myval THV Series vs. Contemporary Valves in severe symptomatic native aortic valve stenosis patients via transfemoral approach. The trial includes a total of 768 subjects across the globe.

Outcomes

The primary outcome is the composite of  the following at 30 days post-procedure:

  • All-cause mortality
  • All stroke
  • Life-threatening or disabling bleeding
  • Acute kidney injury (stage 2 or 3)
  • Major vascular complications
  • Moderate or severe prosthetic valve regurgitation
  • Conduction system disturbances resulting in a new permanent pacemaker implantation
  • Participants will undergo core-lab evaluated echocardiography and ECG at baseline, pre-discharge, 1 month, 1 year and 5 years.

Team:

PI: dr. J.J. Wykrzykowska
SI: drs. C.S. Venema
Project coordinator: G.H. de Jong

External links