Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04275726

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Led by Meril Life Sciences Pvt. Ltd. · Updated on 2025-04-04

988

Participants Needed

54

Research Sites

686 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years of age or older
  • Patient or legal representative has given written informed consent approved by the ethics committee
  • Patient is eligible for TAVI and suitable for implantation with all three study devices as assessed by the local Heart Team
Not Eligible

You will not qualify if you...

  • Patients not willing to provide informed consent or whose legal heirs object to participation
  • Any condition that the Investigator believes would make study participation unsafe

AI-Screening

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Trial Site Locations

Total: 54 locations

1

Republican Scientific-Practical Centre "Cardiology"

Minsk, Belarus, 220036

Not Yet Recruiting

2

Hospital Dante Pazanesse

São Paulo, Brazil, 04012-909

Actively Recruiting

3

Split Clinical Hospital Center

Split, Croatia, 21000

Actively Recruiting

4

University Hospital Dubrava Avenija Gojka Šuška 6

Zagreb, Croatia, 10000

Actively Recruiting

5

North Estonia Medical Center

Tallinn, Estonia

Actively Recruiting

6

Hôpital Henri Mondor

Créteil, France, 94000

Actively Recruiting

7

Lille University

Lille, France, 59000

Actively Recruiting

8

Institut Cardiovascular Paris-Sud

Massy, France, 91300

Actively Recruiting

9

Arnault Tzanck Institute

Nice, France, 06200

Actively Recruiting

10

Centre Hospitalier Universitaire De Rennes

Rennes, France, 35033

Not Yet Recruiting

11

Kerckhoff-KlinikForschungs GmbH

Bad Nauheim, Hesse, Germany, 61231

Actively Recruiting

12

Leipzig Heart Institute GmbH

Leipzig, Saxony, Germany, 04289

Actively Recruiting

13

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

Bad Krozingen, Germany, 79189

Actively Recruiting

14

Klinikum Braunschweig Freisestre

Braunschweig, Germany, 38118

Active, Not Recruiting

15

Technology University Dresden Fetscherstraße 76

Dresden, Germany, 01307

Actively Recruiting

16

Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5

Hamburg, Germany, 20099

Not Yet Recruiting

17

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

Regensburg, Germany, 93053

Actively Recruiting

18

Hippkration Hospital

Athens, Greece, 11527

Actively Recruiting

19

Hygeia hospital

Marousi, Greece

Actively Recruiting

20

Interbalkan European Medical Center

Thessaloniki, Greece, 555 35

Actively Recruiting

21

Semmelweis University

Budapest, Hungary, 1122

Actively Recruiting

22

University of Bologna Policlinico S. Orsola-Malpigh

Bologna, Italy, 40141

Not Yet Recruiting

23

Policlinico di Catania

Catania, Italy, 95100

Not Yet Recruiting

24

San Donato Hospital

Milan, Italy, 20121-20162

Actively Recruiting

25

San Raffaele Hospital

Milan, Italy, 20132

Actively Recruiting

26

Clinical Institute Saint Ambrogio

Milan, Italy, 20149

Actively Recruiting

27

Mauriliano Hospital Largo Filippo

Tortona, Italy, 10128

Not Yet Recruiting

28

University Hospital Città della Salute e della Scienza Turin Bramante

Turin, Italy, 10126

Not Yet Recruiting

29

St Antonius Hospital

Nieuwegein, Dutch, Netherlands, 3435

Actively Recruiting

30

Radboud University Nijmegen

Nijmegen, Gelderland, Netherlands, 6525 XZ

Actively Recruiting

31

Isala Zwolle Hospital

Zwolle, Overijssel, Netherlands, 8025 AB

Active, Not Recruiting

32

Onze lieve vrouwe gasthuis Oosterperk 9

Amsterdam, Netherlands, 1091

Active, Not Recruiting

33

Amphia Ziekenhui Hospital

Breda, Netherlands, 4817

Actively Recruiting

34

University Medical Center (UMC)

Groningen, Netherlands, 9713

Not Yet Recruiting

35

University Medical Center Utrecht

Utrecht, Netherlands, 3584

Actively Recruiting

36

Auckland City Hospital 2 Park Road

Grafton, Auckland, New Zealand, 1023

Actively Recruiting

37

John Paul II Hospital

Krakow, Małopolskie Województwo, Poland, 31-202

Not Yet Recruiting

38

University of Gdansk

Gdansk, Pomorskie Województwo, Poland, 80-952

Not Yet Recruiting

39

Medical University of Silesia

Katowice, Prussian, Poland, 40-635

Not Yet Recruiting

40

Institute of Cardiology

Warsaw, Poland, 50-013

Not Yet Recruiting

41

Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58

Wroclaw, Poland, 50-369

Actively Recruiting

42

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

Carnaxide, Portugal, 2790-134

Actively Recruiting

43

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

Lisbon, Portugal, 1169-024

Actively Recruiting

44

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

Lisbon, Portugal, 1649-028

Not Yet Recruiting

45

Centro Hospitalar de Sao Joao

Porto, Portugal, 4200-319

Not Yet Recruiting

46

University hospital Banska Bystrica Námestie Ludvíka Svobodu 1

Banská Bystrica, Slovakia, 975 17

Actively Recruiting

47

University Medical Center, Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

48

Hospital Universitari Son Espases Carretera de Valldemossa

Palma de Mallorca, Balearic Islands, Spain, 07120

Actively Recruiting

49

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas, Canary Islands, Spain, 35010

Actively Recruiting

50

Hospital Universitario Renei Sofia

Córdoba, Spain, 5000

Actively Recruiting

51

Hospital Clínico San Carlos

Madrid, Spain, 28040

Not Yet Recruiting

52

Hospital Cliinico Univertistario de Valladolid

Valladolid, Spain, 47003

Actively Recruiting

53

Sahlgrenska University Hospital

Gothenburg, Sweden

Actively Recruiting

54

Uppsala University Hospital

Uppsala, Sweden

Actively Recruiting

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Research Team

A

Ashok Thakkar, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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