Clinical Trial

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Study acronym: LANDMARK
Recruiting
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Summary
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)
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-02-17; most recent amendment 2025-04-01.
Status change: Not Yet Recruiting → Recruiting 2022-02-14
Trial Details
NCT Number NCT04275726
Lead Sponsor Meril Life Sciences Pvt. Ltd.
Conditions Aortic Valve Stenosis
Enrollment 988 participants
Start Date 2020-11-04
Primary Completion 2024-03-07 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-04