NCT04275726: LANDMARK

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Recruiting now NA Last updated 4 April 2025

What this trial tests

NA trial testing Myval THV Series in Aortic Valve Stenosis in 988 participants. Currently enrolling.

Timeline

4 November 2020

Primary endpoint
7 March 2024

31 December 2033

Quick facts

Lead sponsor	Meril Life Sciences Pvt. Ltd.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	988
Start date	4 November 2020
Primary completion	7 March 2024
Estimated completion	31 December 2033
Sites	54 locations across France, Italy, Netherlands, New Zealand, Greece, Slovakia, Sweden, Estonia

Drugs / interventions tested

• Myval THV Series
• Contemporary Valves (Sapien THV Series and Evolut THV Series)

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Meril Life Sciences Pvt. Ltd.

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.
   Baumbach A, van Royen N, Amat-Santos IJ, Hudec M, et al · · 2024 · cited 54× · PMID 38795719 · DOI 10.1016/s0140-6736(24)00821-3
2. Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves.
   Kawashima H, Wang R, Mylotte D, Jagielak D, et al · · 2021 · cited 24× · PMID 33833944 · DOI 10.5334/gh.959
3. Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.
   Seth A, Kumar V, Singh VP, Kumar D, et al · · 2023 · cited 16× · PMID 37398875 · DOI 10.15420/icr.2020.32
4. An Update on New Generation Transcatheter Aortic Valves and Delivery Systems.
   Santangelo G, Ielasi A, Pellicano M, Latib A, et al · · 2022 · cited 16× · PMID 35159952 · DOI 10.3390/jcm11030499
5. Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE <i>neo</i>2 versus ACURATE <i>neo</i> Transcatheter Aortic Valve Implantation.
   Rück A, Kim WK, Kawashima H, Abdelshafy M, et al · · 2021 · cited 13× · PMID 34682750 · DOI 10.3390/jcm10204627
6. Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.
   Royen NV, Amat-Santos IJ, Hudec M, Bunc M, et al · · 2025 · cited 8× · PMID 39589296 · DOI 10.4244/eij-d-24-00951
7. One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience.
   Elkoumy A, Jose J, Terkelsen CJ, Nissen H, et al · · 2023 · cited 6× · PMID 36983397 · DOI 10.3390/jcm12062398
8. A European update on transcatheter aortic valve implantation (TAVI) in the COVID era.
   Antony I, Mehari Abraha H, Hameed A, Conway C. · · 2023 · cited 6× · PMID 36152032 · DOI 10.1111/joa.13740