LANDMARK Trial: a Randomised Controlled Trial of Myval THV
NCT ID: NCT04275726
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
988 participants
INTERVENTIONAL
2020-11-04
2033-12-31
Brief Summary
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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)
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Myval THV Series
Myval THV Series will include Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site.
This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.
Myval THV Series
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Contemporary Valves
* Sapien THV Series will consist of Sapien 3/Sapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site.
* Evolut THV Series will include Evolut R/Evolut PRO THVs or any subsequent advanced version commercially available at the study site.
This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.
Contemporary Valves (Sapien THV Series and Evolut THV Series)
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Myval THV Series XL Nested Registry
A non-randomised, nested registry of patients with anatomy of native aortic annulus suitable to be implanted with extra-large size of Myval THV series (30.5mm or 32mm) as per Heart Team assessment/Investigator's discretion is designed. The objective of this registry is to assess the safety and effectiveness of extra-large sizes of Myval THV series. Approximately 100 patients will be recruited from approximately 30 participating centres in LANDMARK Trial
Myval THV Series
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Myval THV Series Lead-in Set
The Lead-in Set aims to ensure investigators adhere to protocol requirements related to the Myval THV Series device, including imaging and procedural guidelines. Investigators should be independent before enrolling study subjects, allowing for valuable feedback for initial safety assessments. Each investigator must conduct at least two non-randomized lead-in cases under the guidance of an evaluation committee. Lead-in subjects will only receive the study device, and if implantation fails, standard care will be provided. These subjects will not be included in primary or secondary endpoint analyses but will undergo descriptive analysis. Unique numbers will be assigned to all lead-in subjects, and the committee will evaluate outcomes and site independence for future trial recruitment.
Myval THV Series
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Interventions
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Myval THV Series
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Contemporary Valves (Sapien THV Series and Evolut THV Series)
The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient or their legal representative has provided written informed consent as approved 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 is suitable for implantation with all three study devices.
Exclusion Criteria
2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
18 Years
ALL
No
Sponsors
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Meril Life Sciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Baumbach, MD,FESC,FRCP
Role: STUDY_CHAIR
Barts Heart Center, London, UK
Patrick W. Serruys, MD,PhD,FACC,FESC
Role: STUDY_DIRECTOR
National University of Ireland, Galway, Ireland
Locations
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Republican Scientific-Practical Centre "Cardiology"
Minsk, , Belarus
Hospital Dante Pazanesse
São Paulo, , Brazil
Split Clinical Hospital Center
Split, , Croatia
University Hospital Dubrava Avenija Gojka Šuška 6
Zagreb, , Croatia
North Estonia Medical Center
Tallinn, , Estonia
Hôpital Henri Mondor
Créteil, , France
Lille University
Lille, , France
Institut Cardiovascular Paris-Sud
Massy, , France
Arnault Tzanck Institute
Nice, , France
Centre Hospitalier Universitaire De Rennes
Rennes, , France
Kerckhoff-KlinikForschungs GmbH
Bad Nauheim, Hesse, Germany
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
Bad Krozingen, , Germany
Klinikum Braunschweig Freisestre
Braunschweig, , Germany
Technology University Dresden Fetscherstraße 76
Dresden, , Germany
Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
Hamburg, , Germany
Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
Regensburg, , Germany
Hippkration Hospital
Athens, , Greece
Hygeia hospital
Marousi, , Greece
Interbalkan European Medical Center
Thessaloniki, , Greece
Semmelweis University
Budapest, , Hungary
University of Bologna Policlinico S. Orsola-Malpigh
Bologna, , Italy
Policlinico di Catania
Catania, , Italy
San Donato Hospital
Milan, , Italy
San Raffaele Hospital
Milan, , Italy
Clinical Institute Saint Ambrogio
Milan, , Italy
Mauriliano Hospital Largo Filippo
Tortona, , Italy
University Hospital Città della Salute e della Scienza Turin Bramante
Turin, , Italy
St Antonius Hospital
Nieuwegein, Dutch, Netherlands
Radboud University Nijmegen
Nijmegen, Gelderland, Netherlands
Isala Zwolle Hospital
Zwolle, Overijssel, Netherlands
Onze lieve vrouwe gasthuis Oosterperk 9
Amsterdam, , Netherlands
Amphia Ziekenhui Hospital
Breda, , Netherlands
University Medical Center (UMC)
Groningen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Auckland City Hospital 2 Park Road
Grafton, Auckland, New Zealand
John Paul II Hospital
Krakow, Małopolskie Województwo, Poland
University of Gdansk
Gdansk, Pomorskie Województwo, Poland
Medical University of Silesia
Katowice, Prussian, Poland
Institute of Cardiology
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58
Wroclaw, , Poland
Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos
Carnaxide, , Portugal
Centro Hospital Lisboa Central E.P.E. - Santa Marta
Lisbon, , Portugal
Hospital de Santa Maria, Av. Prof. Egas Moniz MB
Lisbon, , Portugal
Centro Hospitalar de Sao Joao
Porto, , Portugal
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
Banská Bystrica, , Slovakia
University Medical Center, Ljubljana
Ljubljana, , Slovenia
Hospital Universitari Son Espases Carretera de Valldemossa
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas, Canary Islands, Spain
Hospital Universitario Renei Sofia
Córdoba, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Cliinico Univertistario de Valladolid
Valladolid, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Dr. Peep Laanmets
Role: primary
Prof. Dr. Giuseppe Musumeci
Role: primary
Dr n. med Jaroslaw Trebacz, MD PhD
Role: primary
References
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Kawashima H, Soliman O, Wang R, Ono M, Hara H, Gao C, Zeller E, Thakkar A, Tamburino C, Bedogni F, Neumann FJ, Thiele H, Abdel-Wahab M, Morice MC, Webster M, Rosseel L, Mylotte D, Onuma Y, Wijns W, Baumbach A, Serruys PW. 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. Am Heart J. 2021 Feb;232:23-38. doi: 10.1016/j.ahj.2020.11.001. Epub 2020 Nov 6.
Tobe A, Onuma Y, Soliman O, Baumbach A, Serruys PW. LANDMARK trial: Update in study protocol. Am Heart J. 2024 Apr;270:162-163. doi: 10.1016/j.ahj.2024.02.008. Epub 2024 Feb 16. No abstract available.
Baumbach A, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, Ijsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Ninios V, Protasiewicz M, Rensing BJWM, Martin PL, Feres F, De Sousa Almeida M, van Belle E, Linke A, Ielasi A, Montorfano M, Webster M, Toutouzas K, Teiger E, Bedogni F, Voskuil M, Pan M, Angeras O, Kim WK, Rothe J, Kristic I, Peral V, Garg S, Elzomor H, Tobe A, Morice MC, Onuma Y, Soliman O, Serruys PW; LANDMARK trial investigators. 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. Lancet. 2024 Jun 22;403(10445):2695-2708. doi: 10.1016/S0140-6736(24)00821-3. Epub 2024 May 22.
Royen NV, Amat-Santos IJ, Hudec M, Bunc M, Ijsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Ninios V, Protasiewicz M, Rensing BJWM, Martin PL, Feres F, Sousa M, Belle EV, Linke A, Ielasi A, Montorfano M, Webster M, Toutouzas K, Teiger E, Bedogni F, Voskuil M, Pan M, Angeras O, Kim WK, Rothe J, Kristic I, Peral V, Van den Branden BJL, Westermann D, Bellini B, Garcia-Gomez M, Tobe A, Tsai TY, Garg S, Thakkar A, Chandra U, Morice MC, Soliman O, Onuma Y, Serruys PW, Baumbach A. Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis. EuroIntervention. 2025 Jan 20;21(2):e105-e118. doi: 10.4244/EIJ-D-24-00951.
Kawashima H, Wang R, Mylotte D, Jagielak D, De Marco F, Ielasi A, Onuma Y, den Heijer P, Terkelsen CJ, Wijns W, Serruys PW, Soliman O. Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves. Glob Heart. 2021 Mar 19;16(1):20. doi: 10.5334/gh.959.
Related Links
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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
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.
Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis. EuroIntervention
LANDMARK trial: Update in study protocol.
Other Identifiers
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2020-000137-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MLS/MYV-2/LANDMARK
Identifier Type: -
Identifier Source: org_study_id
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