LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Last updated: April 1, 2025
Sponsor: Meril Life Sciences Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Contemporary Valves (Sapien THV Series and Evolut THV Series)

Myval THV Series

Clinical Study ID

NCT04275726
MLS/MYV-2/LANDMARK
2020-000137-40
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥18 years of age.

  2. Patient or their legal representative has provided written informed consent asapproved 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 issuitable for implantation with all three study devices.

Exclusion

Exclusion Criteria:

  1. Patients who are not willing to provide informed consent form, or whose legal heirsobject to their participation in the study.

  2. Any condition, which in the Investigator's opinion, would preclude safeparticipation of patient in the study.

Study Design

Total Participants: 988
Treatment Group(s): 2
Primary Treatment: Contemporary Valves (Sapien THV Series and Evolut THV Series)
Phase:
Study Start date:
November 04, 2020
Estimated Completion Date:
December 31, 2033

Study Description

LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach.

  • Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter.

  • Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter.

  • Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter.

A non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry)

  • Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm.

A non-randomized registry will include patients implanted with the Myval THV Series (Lead-in Set).

  • The investigators have to perform a minimum of 2 lead-in cases (non-randomised) under the guidance of the lead-in evaluation committee.

Connect with a study center

  • Medical University of Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Republican Scientific-Practical Centre "Cardiology"

    Minsk, 220036
    Belarus

    Site Not Available

  • Hospital Dante Pazanesse

    São Paulo, 04012-909
    Brazil

    Active - Recruiting

  • Clinical Hospital Center

    Rijeka, 51000
    Croatia

    Site Not Available

  • Split Clinical Hospital Center

    Split, 21000
    Croatia

    Active - Recruiting

  • University Hospital Dubrava Avenija Gojka Šuška 6

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • North Estonia Medical Center

    Tallinn,
    Estonia

    Active - Recruiting

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Active - Recruiting

  • Lille University

    Lille, 59000
    France

    Active - Recruiting

  • Institut Cardiovascular Paris-Sud

    Massy, 91300
    France

    Active - Recruiting

  • Arnault Tzanck Institute

    Nice, 06200
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire De Rennes

    Rennes, 35033
    France

    Site Not Available

  • Kerckhoff-KlinikForschungs GmbH

    Bad Nauheim, Hesse 61231
    Germany

    Active - Recruiting

  • Leipzig Heart Institute GmbH

    Leipzig, Saxony 04289
    Germany

    Active - Recruiting

  • University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15

    Bad Krozingen, 79189
    Germany

    Active - Recruiting

  • Klinikum Braunschweig Freisestre

    Braunschweig, 38118
    Germany

    Site Not Available

  • Technology University Dresden Fetscherstraße 76

    Dresden, 01307
    Germany

    Active - Recruiting

  • Contilia Heart and Vascular Center Freisestre, 9/10

    Essen, 145138
    Germany

    Site Not Available

  • Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5

    Hamburg, 20099
    Germany

    Site Not Available

  • Ludwig - Maximilians - Universität München Geschwister - Scholl - Platz

    München, 80539
    Germany

    Site Not Available

  • Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Hippkration Hospital

    Athens, 11527
    Greece

    Active - Recruiting

  • Hygeia hospital

    Maroúsi,
    Greece

    Active - Recruiting

  • Interbalkan European Medical Center

    Thessaloniki, 555 35
    Greece

    Active - Recruiting

  • Interbalkan European Medical Center

    Thessaloníki, 555 35
    Greece

    Site Not Available

  • Semmelweis University

    Budapest, 1122
    Hungary

    Active - Recruiting

  • University of Bologna Policlinico S. Orsola-Malpigh

    Bologna, 40141
    Italy

    Site Not Available

  • Policlinico di Catania

    Catania, 95100
    Italy

    Site Not Available

  • San Donato Hospital

    Milan, 20121-20162
    Italy

    Active - Recruiting

  • Clinical Institute Saint Ambrogio

    Milano, 20149
    Italy

    Active - Recruiting

  • Clinical Institute Saint Ambrogio Via Luigi Giuseppe Faravelli

    Milano, 20149
    Italy

    Site Not Available

  • San Raffaele Hospital

    Milano, 20132
    Italy

    Active - Recruiting

  • Mauriliano Hospital Largo Filippo

    Tortona, 10128
    Italy

    Site Not Available

  • University Hospital Città della Salute e della Scienza Turin Bramante

    Turin, 10126
    Italy

    Site Not Available

  • St Antonius Hospital

    Nieuwegein, Dutch 3435
    Netherlands

    Active - Recruiting

  • Radboud University Nijmegen

    Nijmegen, Gelderland 6525 XZ
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhui

    Breda, North Brabant 4818
    Netherlands

    Site Not Available

  • Isala Zwolle Hospital

    Zwolle, Overijssel 8025 AB
    Netherlands

    Site Not Available

  • Onze lieve vrouwe gasthuis Oosterperk 9

    Amsterdam, 1091
    Netherlands

    Site Not Available

  • Amphia Ziekenhui Hospital

    Breda, 4817
    Netherlands

    Active - Recruiting

  • University Medical Center (UMC)

    Groningen, 9713
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht, 3584
    Netherlands

    Active - Recruiting

  • Auckland City Hospital 2 Park Road

    Grafton, Auckland 1023
    New Zealand

    Active - Recruiting

  • John Paul II Hospital

    Krakow, Małopolskie Województwo 31-202
    Poland

    Site Not Available

  • University of Gdansk

    Gdańsk, Pomorskie Województwo 80-952
    Poland

    Site Not Available

  • Medical University of Silesia

    Katowice, Prussian 40-635
    Poland

    Site Not Available

  • Institute of Cardiology

    Warsaw, 50-013
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58

    Wrocław, 50-369
    Poland

    Active - Recruiting

  • Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos

    Carnaxide, 2790-134
    Portugal

    Active - Recruiting

  • Hospital de Santa Maria, Av. Prof. Egas Moniz MB

    Lisboa, 1649-028
    Portugal

    Site Not Available

  • Centro Hospital Lisboa Central E.P.E. - Santa Marta

    Lisbon, 1169-024
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Sao Joao

    Porto, 4200-319
    Portugal

    Site Not Available

  • University hospital Banska Bystrica Námestie Ludvíka Svobodu 1

    Banská Bystrica, 975 17
    Slovakia

    Active - Recruiting

  • University Medical Center, Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrin

    Las Palmas, Canary Islands 35010
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases Carretera de Valldemossa

    Palma De Mallorca, Illes Balears 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Renei Sofia

    Córdoba, 5000
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Virgen de la Arrixaca University Hospital

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Cliinico Univertistario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Active - Recruiting

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