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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial
American Heart Journal, Volume 232, Year 2021
Notification
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Description
Background: The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. Methods/Design: The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020–000,137–40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial. © 2020 The Authors
Authors & Co-Authors
Kawashima, Hideyuki
Ireland, Galway
University of Galway
Netherlands, Amsterdam
Universiteit Van Amsterdam
Soliman, O. I.I.
Ireland, Galway
University of Galway
Wang, Rutao
Ireland, Galway
University of Galway
Netherlands, Nijmegen
Radboud University Medical Center
Ono, Masafumi
Ireland, Galway
University of Galway
Netherlands, Amsterdam
Universiteit Van Amsterdam
Hara, Hironori
Ireland, Galway
University of Galway
Netherlands, Amsterdam
Universiteit Van Amsterdam
Gao, Chao
Ireland, Galway
University of Galway
Netherlands, Nijmegen
Radboud University Medical Center
Tamburino, Corrado
Italy, Catania
Azienda Ospedaliero Universitaria Policlinico G.rodolico - San Marco
Bedogni, Francesco
Italy, San Donato Milanese
Gruppo Ospedaliero San Donato
Neumann, Franz Josef
Germany, Bad Krozingen
Universitäts Herzzentrum Freiburg Bad Krozingen
Thiele, Holger
Germany, Leipzig
Herzzentrum Leipzig
Abdel-Wahab, Mohamed Kader
Germany, Leipzig
Herzzentrum Leipzig
Morice, Marie Claude
Unknown Affiliation
Rosseel, Liesbeth
Ireland, Galway
University of Galway
Mylotte, Darren M.
Ireland, Galway
University of Galway
Onuma, Yosinobu
Ireland, Galway
University of Galway
Wijns, William C.
Ireland, Galway
University of Galway
Baumbach, Andreas
United Kingdom, London
Queen Mary University of London
Serruys, Patrick W.
Ireland, Galway
University of Galway
United Kingdom, London
Imperial College London
Statistics
Citations: 21
Authors: 18
Affiliations: 10
Identifiers
Doi:
10.1016/j.ahj.2020.11.001
ISSN:
00028703
Research Areas
Noncommunicable Diseases
Violence And Injury
Study Design
Randomised Control Trial
Cohort Study