LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Key facts
- Where
- Banská Bystrica, SlovakiaSee the site
Where in Slovakia
- University hospital Banska Bystrica Námestie Ludvíka Svobodu 1Banská Bystrica, SlovakiaContact: Dr. Martin HudecTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Meril Life Sciences Pvt. Ltd.
- Trial code
- NCT04275726
- Record updated
- 17 August 2026
- Original description
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.Read full original descriptionShow less
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
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.
This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)
The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)
Inclusion: Patient ≥18 years of age; 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; As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
Exclusion: Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study; Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.