Actively Recruiting
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
Eligibility Criteria
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
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
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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