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Comparing Myval THV with Contemporary Valves for Aortic Valve Stenosis

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's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis

Not applicable Interventional Meril Life Sciences Pvt. Ltd. · NCT04275726

This study is testing if a new heart valve called Myval works better and is safer than current heart valves for people with severe aortic valve narrowing.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment988 (estimated)
Ages18 Years and up
SexAll
SponsorMeril Life Sciences Pvt. Ltd. Industry-sponsored
Locations54 sites (Minsk and 53 other locations)
Trial IDNCT04275726 on ClinicalTrials.gov

What this trial studies

The LANDMARK Trial is a randomized controlled trial designed to evaluate the safety and effectiveness of the Myval THV Series compared to contemporary valves, specifically the Sapien and Evolut THV Series, in patients suffering from severe symptomatic native aortic valve stenosis. This multicentric, open-label trial will enroll a total of 768 subjects, with participants randomly assigned in a 1:1 ratio to receive either the Myval THV or one of the contemporary valves. The study aims to assess outcomes through a transfemoral approach and includes a nested registry for patients requiring extra-large valve sizes. The trial will also involve a lead-in set for initial cases to ensure proper implantation techniques.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are eligible for transcatheter aortic valve implantation (TAVI) and can provide informed consent.

Not a fit: Patients who are not suitable for TAVI or those unwilling to participate in the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide a new effective treatment option for patients with severe aortic valve stenosis.

How similar studies have performed: Previous studies comparing similar transcatheter heart valves have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient ≥18 years of age.
2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study.
3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.

Exclusion Criteria:

1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

Where this trial is running

Minsk and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Valve StenosisLANDMARK TrialTrial to evaluate safety & effectiveness of Myval THVCE Approved Myval THV Series
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.