Aortic Valve StenosisLANDMARKNCT04275726
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
A study testing Myval THV Series and Contemporary Valves (Sapien THV Series and Evolut THV Series) in people with Aortic Valve Stenosis, run by Meril Life Sciences Pvt. Ltd. at 54 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Myval THV Series and Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 988 participants
- Where
- 54 sitesin 17 countries
- Study dates
- 4 Nov 2020to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥18 years of age.
- 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.
- As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
Who cannot join
- Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Trial locations and contacts
54 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 17 countries
Germany7 sites, 6 recruiting
- Recruiting
University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
Bad Krozingen, 79189
Dr. Jurgen Rothe, juergen.rothe@uniklinik-freiburg.de
- Recruiting
Kerckhoff-KlinikForschungs GmbH
Bad Nauheim, Hesse, 61231
Dr. Won K Kim, M.D, +49 60326152, w.kim@kerckhoff-klinik.de
- Active, not recruiting
Klinikum Braunschweig Freisestre
Braunschweig, 38118
- Recruiting
Technology University Dresden Fetscherstraße 76
Dresden, 01307
Prof. Dr. Axel Linke, Axel.Linke@herzzentrum-dresden.com
- Not yet recruiting
Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
Hamburg, 20099
Dr. Samer Hakmi, MD, samer@hakmi.des.hakmi@asklepois.com
- Recruiting
Leipzig Heart Institute GmbH
Leipzig, Saxony, 04289
Prof Mohamed A Wahab, Ph. D, +493418650, mohamed.abdel-wahab@medizin.uni-leipzig.de
- Recruiting
Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
Regensburg, 93053
Dr. med. Andreas Holzamer, andreas.holzamer@klinik.uni-regensburg.de
Prof. Dr. Med. Michael Hilker
Italy7 sites, 7 recruiting
- Not yet recruiting
University of Bologna Policlinico S. Orsola-Malpigh
Bologna, 40141
Dr. Francesco Saia, francescosaia@hotmail.com
- Not yet recruiting
Policlinico di Catania
Catania, 95100
Dr. Corrado Tamburino, tambucor@unict.it
- Recruiting
San Donato Hospital
Milan, 20121-20162
Dr. Francesco Bedogni, + 39 335 5309117, Francesco.bedogni@grupposandonato.it
- Recruiting
San Raffaele Hospital
Milan, 20132
Dr. Matteo Montorfano, +39 02 26437331, montorfano.matteo@hsr.it
Dr.BELLINI BARBARA
- Recruiting
Clinical Institute Saint Ambrogio
Milan, 20149
Dr. Alfonso Ielasi, +39 338 8433189, alielasi@hotmail.com
- Not yet recruiting
Mauriliano Hospital Largo Filippo
Tortona, 10128
Prof. Dr. Giuseppe Musumeci
- Not yet recruiting
University Hospital Città della Salute e della Scienza Turin Bramante
Turin, 10126
Prof Gaetano Maria De Ferrari, 011 6334634, gaetanomaria.deferrari@unito.it
Netherlands7 sites, 5 recruiting
- Active, not recruiting
Onze lieve vrouwe gasthuis Oosterperk 9
Amsterdam, 1091
- Recruiting
Amphia Ziekenhui Hospital
Breda, 4817
Dr. Van Den Branden, PhD, +31613000745, bvandenbranden@amphia.nl
- Not yet recruiting
University Medical Center (UMC)
Groningen, 9713
Dr. Joanna J Wykrzykowska, +31-630367425, joannawykrzykowska70@gmail.com/ j.wykrzykowska@amsterdamumc.nl
- Recruiting
St Antonius Hospital
Nieuwegein, Dutch, 3435
Dr. B.J.W.M Rensing, Cardiologist, +31 306093974, b.rensing@antoniusziekenhuis.nl
- Recruiting
Radboud University Nijmegen
Nijmegen, Gelderland, 6525 XZ
Prof. Niels V Royen, Ph.D, niels.vanroyen@radboudumc.nl
- Recruiting
University Medical Center Utrecht
Utrecht, 3584
Dr. Michiel Voskuil, mvoskuil@umcutrecht.nl
- Active, not recruiting
Isala Zwolle Hospital
Zwolle, Overijssel, 8025 AB
France5 sites, 5 recruiting
- Recruiting
Hôpital Henri Mondor
Créteil, 94000
Prof. Emmanuel Teiger, emmanuel.teiger@aphp.fr
- Recruiting
Lille University
Lille, 59000
Prof. Eric Van Belle, ericvanbelle@aol.com
- Recruiting
Institut Cardiovascular Paris-Sud
Massy, 91300
Dr. Bernard Chevalier, bchevali@aol.com
- Recruiting
Arnault Tzanck Institute
Nice, 06200
Dr. ADJEDJ Julien, juliendjdj@gmail.com
- Not yet recruiting
Centre Hospitalier Universitaire De Rennes
Rennes, 35033
Dr. Vincent Auffret, vincent.auffret@chu-rennes.fr
Poland5 sites, 5 recruiting
- Not yet recruiting
University of Gdansk
Gdansk, Pomorskie Województwo, 80-952
Prof. Darius Jageilak, MD PhD, +48585844200, darjag@gumed.edu.pl
Radoslaw Targonski, MD PhD
- Not yet recruiting
Medical University of Silesia
Katowice, Prussian, 40-635
Dr. Wojciech Wojakowski, MD PhD, wwojakowski@sum.edu.pl
- Not yet recruiting
John Paul II Hospital
Krakow, Małopolskie Województwo, 31-202
Dr n. med Jaroslaw Trebacz, MD PhD
- Not yet recruiting
Institute of Cardiology
Warsaw, 50-013
Prof. Adam Witkowski, MD, PhD, FESC, +48 22 812 41 64, witkowski@hbz.pl
- Recruiting
Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58
Wroclaw, 50-369
Dr. Marcin Protasiewicz, +48 71 7364200, marcin.protasiewicz@umed.wwroc.pl
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Renei Sofia
Córdoba, 5000
Dr. Manuel Pan, manuelpanalvarez@gmail.com
- Recruiting
Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas, Canary Islands, 35010
Dr. Pedro Martin Lorenzo, +34928450000, pemarlor@hotmail.com
- Not yet recruiting
Hospital Clínico San Carlos
Madrid, 28040
Dr. Luis Nombela, MD, PhD, +34629510139, luisnombela@yahoo.com
- Recruiting
Hospital Universitari Son Espases Carretera de Valldemossa
Palma de Mallorca, Balearic Islands, 07120
Dr. Vicente Peral, +34 871205381, vicente.peral@ssib.es
Dr. Tania Rdgz Gabella
- Recruiting
Hospital Cliinico Univertistario de Valladolid
Valladolid, 47003
Dr. Ignacio A Santos, Medicine & Surgery, +34657923040, ijamat@gmail.com
Dr. Juan Pablo Sánchez Luna, MD, PhD
Portugal4 sites, 4 recruiting
- Recruiting
Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos
Carnaxide, 2790-134
Dr. Manuel Almeida, +351 936359285, almeidams@sapo.pt
- Recruiting
Centro Hospital Lisboa Central E.P.E. - Santa Marta
Lisbon, 1169-024
Dr. Duarte Cacela, dcacela@hotmail.com
- Not yet recruiting
Hospital de Santa Maria, Av. Prof. Egas Moniz MB
Lisbon, 1649-028
Dr. Pedro Carrilho Ferreira, +351 966 412 473, pcarrilhoferreira@gmail.com
- Not yet recruiting
Centro Hospitalar de Sao Joao
Porto, 4200-319
Dr. Joao Carlos Silva, PhD, joaocebsilva@hotmail.com
Greece3 sites, 3 recruiting
- Recruiting
Hippkration Hospital
Athens, 11527
Prof. Konstantinos Toutouzas, +30 2132088026, ktoutouz@gmail.com
- Recruiting
Hygeia hospital
Marousi
Dr. Konstantinos Spargias, Spargiaskspargias@hygeia.gr
- Recruiting
Interbalkan European Medical Center
Thessaloniki, 555 35
Dr. Vlasis Ninios, +302310400929, vninios@gmail.com
Croatia2 sites, 2 recruiting
- Recruiting
Split Clinical Hospital Center
Split, 21000
Dr. Ivica Kristic, MD, PhD, kristicivica@gmail.com
- Recruiting
University Hospital Dubrava Avenija Gojka Šuška 6
Zagreb, 10000
Dr. Daniel Unić, MD, +385989196621, unic@kbd.hr
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Dr. Oskar Angreas, oskar.angeras@vgregion.se
- Recruiting
Uppsala University Hospital
Uppsala
Prof. Stefan James, stefan.james@ucr.uu.se
Belarus1 site, 1 recruiting
- Not yet recruiting
Republican Scientific-Practical Centre "Cardiology"
Minsk, 220036
Dr. Oleg Polonetsky, MD, PhD, polonetsky@yandex.ru
Brazil1 site, 1 recruiting
- Recruiting
Hospital Dante Pazanesse
São Paulo, 04012-909
Dr. Fausto Feres, fferes@dantepazzanese.org.br
Andrea Vilela,
Estonia1 site, 1 recruiting
- Recruiting
North Estonia Medical Center
Tallinn
Dr. Peep Laanmets
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest, 1122
Prof. Bela Merkely, MD Ph. D, 36206632488, merkely.bela@kardio.sote.hu
Dr. Roland Papp, MD
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital 2 Park Road
Grafton, Auckland, 1023
Dr. Mark Webster, MD, +64 9 307 4949, mwebster@adhb.govt.nz
Slovakia1 site, 1 recruiting
- Recruiting
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
Banská Bystrica, 975 17
Dr. Martin Hudec, +421 918 106033, hudecmt@hotmail.com
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center, Ljubljana
Ljubljana, 1000
Prof. Matjaz Bunc, MD, PhD, +38615225050, matjaz.bunc@kclj.si
About this study
Official title: A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
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)
Read the detailed 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Myval THV Series, Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Keywords
- LANDMARK Trial, Trial to evaluate safety & effectiveness of Myval THV, CE Approved Myval THV Series
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myval THV SeriesDevice
Also called Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site.
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)Device
Also called Sapien THV Series (Sapien 3/Sapien 3 Ultra THVs) and Evolut THV Series (Evolut R/Evolut PRO THVs ) or any subsequent advanced version commercially available at the study site.
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.
| Study group | Role | What they receive |
|---|---|---|
| Myval THV Series | Experimental | 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. Receives: Device: Myval THV Series |
| Contemporary Valves | Active comparator | * 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. Receives: Device: Contemporary Valves (Sapien THV Series and Evolut THV Series) |
| Myval THV Series XL Nested Registry | Experimental | 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 Receives: Device: Myval THV Series |
| Myval THV Series Lead-in Set | Experimental | 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. Receives: Device: Myval THV Series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
It is the composite of following:
- All-cause mortality
- All stroke
- Bleeding (Type 3 and 4)
- Acute kidney injury (AKI) (Stage 2, 3 and 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new PPI
Measured: 30-day
Secondary outcomes (33)
The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
It is the composite of following:
- All-cause mortality
- All stroke
- Bleeding (Type 3 and 4)
- AKI (Stage 2, 3 and 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new PPI
Measured: 1-year
All-cause mortality
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year
All stroke
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Acute Kidney Injury (AKI) (Stage 2, 3 and 4)
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, and 1-year
Bleeding (Type 3 and 4)
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Moderate or severe prosthetic valve regurgitation
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
New permanent pacemaker implantation (As per VARC-3 defined criteria)
- New PPI rates will be analysed further based on the patient's history of left and/or right bundle branch block.
Measured: Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year, and 10-year
Conduction disturbances and arrhythmias
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Device success
As per VARC-3 defined criteria
Measured: Pre-discharge and 30-day
Early safety at 30 days
As per VARC-3 defined criteria
Measured: 30-day
Clinical efficacy at 30 days
As per VARC-3 defined criteria
Measured: After 30 days of index procedure
Valve related long-term clinical efficacy
As per VARC-3 defined criteria
Measured: 5-years, 7 years and 10 years
Vascular and access related complications
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, and 1-year
Major vascular complications
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, and 1-year
Functional improvement from baseline as measured per
New York Heart Association (NYHA) functional classification [Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year] Six-minute walk test [Time frame: Baseline (pre-procedure), 30-day and 1-year]
Measured: [Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year], [Time frame: Baseline (pre-procedure), 30-day and 1-year]
Echocardiographic endpoints
- Effective orifice area (EOA)
- Index effective orifice area (iEOA)
- Mean aortic valve gradient
- Peak aortic valve gradient
- Peak aortic velocity
- Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline)
- Left ventricular ejection fraction (LVEF)
- Valve calcification
- Cardiac output and cardiac index
Measured: Baseline, pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Bioprosthetic valve deterioration
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Patient-prosthesis mismatch
Severity patient-prosthesis-mismatch will be based on following
- For subjects with body mass index (BMI) <30 kg/m2, EOAi: 0.85 - 0.66 cm2 /m2 considered as moderate and ≤0.65 cm2 /m2 considered as severe
- For subjects with BMI ≥30 kg/m2, EOAi: 0.70 - 0.56 cm2 /m2 considered as moderate and ≤0.55 cm2 /m2 considered as severe
- BMI = weight(kg)/(height (m))2
Measured: Pre-discharge, 30-day, and 1-year
Length of index hospital stay
- Number of days from hospital admission to discharge.
Measured: At discharge
Re-hospitalization
As per VARC-3 defined criteria
Measured: 30-day, 1-year, 3-year, and 5-year
Health status as evaluated by Quality of Life questionnaires
- 12-Item Short Form Survey (SF-12)
Measured: Baseline (pre-procedure), 30-day, and 1-year
Valve thrombosis
- Valve thrombosis as per VARC-2 is any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis.
Measured: 30-day, 1-year, 3-year, and 5-year
Coronary obstruction requiring intervention
As per VARC-3 defined criteria
Measured: Pre-discharge
Valve malpositioning
As per VARC-3 defined criteria
Measured: Pre-discharge
Conversion to open surgery
As per VARC-3 defined criteria
Measured: Pre-discharge
Unplanned use of mechanical circulatory support (cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), transcatheter pumps or intra-aortic balloon pump (IABP)
As per VARC-3 defined criteria
Measured: Pre-discharge
Implantation of multiple (>1) transcatheter valves during the index hospitalization
As per VARC-3 defined criteria
Measured: Index-procedure
Cardiac structural complications
As per VARC-3 defined criteria
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Ventricular septal perforation
- Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure
Measured: Pre-discharge
New onset of atrial fibrillation or atrial flutter
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Technical success
As per VARC-3 defined criteria
Measured: Post-procedure
Myocardial Infarction
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Endocarditis
As per VARC-3 defined criteria
Measured: 30-day, 1-year, 3-year, and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start4 Nov 2020
- Primary completion7 Mar 2024
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 988 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Baumbach, MD,FESC,FRCP, Study chair, Barts Heart Center, London, UKPatrick W. Serruys, MD,PhD,FACC,FESC, Study director, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275726
- Sponsor's protocol ID
- MLS/MYV-2/LANDMARK
- Other IDs
- 2020-000137-40
- Acronym
- LANDMARK
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2020
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38369219Baumbach 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.
PubMed 38795719Royen 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.
PubMed 39589296Hasabo EA, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, IJsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Ninios V, Protasiewicz M, W M Rensing BJ, Martin PL, Feres F, 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, Van den Branden BJL, Thakkar A, Chandra U, Ayhan C, Neiroukh D, Nosir MY, Yacoub MS, Ali S, Altamimi M, Elzomor H, Serruys PW, Baumbach A, Soliman O. Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial. Int J Cardiol Heart Vasc. 2025 Sep 29;61:101804. doi: 10.1016/j.ijcha.2025.101804. eCollection 2025 Dec.
PubMed 41079007Serruys PW, Tobe A, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, Van den Branden BJL, 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, Abdel-Wahab M, Kristic I, Peral V, Garg S, Tsai TY, Thakkar A, Chandra U, Smits PC, Morice MC, Onuma Y, Baumbach A; LANDMARK Investigators. 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial. J Am Coll Cardiol. 2026 Feb 3;87(4):362-381. doi: 10.1016/j.jacc.2025.10.076. Epub 2025 Nov 16.
PubMed 41384893Tobe A, Onuma Y, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, van den Branden BJL, 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, Abdel-Wahab M, Kristic I, Peral V, Garg S, Thakkar A, Chandra U, Smits PC, Morice MC, Baumbach A, Serruys PW. Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial. Struct Heart. 2026 Jul 24;10(9):101101. doi: 10.1016/j.shj.2026.101101. eCollection 2026 Sep.
PubMed 42701683Soliman O, Hasabo EA, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, IJsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Mouden M, Ninios V, Protasiewicz M, Rensing BJWM, Martin PL, Feres F, Almeida MS, van Belle E, Linke A, Ielasi A, Montorfano M, Webster M, Toutouzas K, Teiger E, Bedogni F, Voskuil M, Rubio DM, Angeras O, Kim WK, Rothe J, Kristic I, Peral V, Van den Branden BJL, Thakkar A, Chandra U, Neiroukh D, Ayhan C, Nosir MY, Yacoub MS, Ali S, Altamimi M, Elzomor H, Serruys PW, Baumbach A. Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial. Eur Heart J Cardiovasc Imaging. 2026 Feb 9;27(2):247-260. doi: 10.1093/ehjci/jeaf245.
PubMed 40875489Kawashima 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.
PubMed 33833944Kawashima 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.
PubMed 33160946
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT04275726
- Acronym / sponsor ID
- LANDMARK / MLS/MYV-2/LANDMARK
- Conditions
- Aortic Valve Stenosis
- Keywords
- LANDMARK Trial, Trial to evaluate safety & effectiveness of Myval THV, CE Approved Myval THV Series
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 988 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Myval THV Series | Experimental | Device: Myval THV SeriesMyval 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. |
| Contemporary Valves | Active comparator | Device: Contemporary Valves (Sapien THV Series and Evolut THV Series)* 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. |
| Myval THV Series XL Nested Registry | Experimental | Device: Myval THV SeriesA 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 Lead-in Set | Experimental | Device: Myval THV SeriesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥18 years of age.
- 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.
- As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
Key exclusion criteria (2 listed)
- Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myval THV SeriesAlso: Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site.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. | Device | Myval THV Series, Myval THV Series Lead-in Set, Myval THV Series XL Nested Registry |
| Contemporary Valves (Sapien THV Series and Evolut THV Series)Also: Sapien THV Series (Sapien 3/Sapien 3 Ultra THVs) and Evolut THV Series (Evolut R/Evolut PRO THVs ) or any subsequent advanced version commercially available at the study site.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. | Device | Contemporary Valves |
Primary outcome
Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 30-day
It is the composite of following: * All-cause mortality * All stroke * Bleeding (Type 3 and 4) * Acute kidney injury (AKI) (Stage 2, 3 and 4) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new PPI
33 secondary outcomes
The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
Time frame: 1-year
All-cause mortality
Time frame: Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year
All stroke
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Acute Kidney Injury (AKI) (Stage 2, 3 and 4)
Time frame: Pre-discharge, 30-day, and 1-year
Bleeding (Type 3 and 4)
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Moderate or severe prosthetic valve regurgitation
Time frame: Pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
New permanent pacemaker implantation (As per VARC-3 defined criteria)
Time frame: Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year, and 10-year
Conduction disturbances and arrhythmias
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Device success
Time frame: Pre-discharge and 30-day
Early safety at 30 days
Time frame: 30-day
Clinical efficacy at 30 days
Time frame: After 30 days of index procedure
Valve related long-term clinical efficacy
Time frame: 5-years, 7 years and 10 years
Vascular and access related complications
Time frame: Pre-discharge, 30-day, and 1-year
Major vascular complications
Time frame: Pre-discharge, 30-day, and 1-year
Functional improvement from baseline as measured per
Time frame: [Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year], [Time frame: Baseline (pre-procedure), 30-day and 1-year]
Echocardiographic endpoints
Time frame: Baseline, pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Bioprosthetic valve deterioration
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Patient-prosthesis mismatch
Time frame: Pre-discharge, 30-day, and 1-year
Length of index hospital stay
Time frame: At discharge
Re-hospitalization
Time frame: 30-day, 1-year, 3-year, and 5-year
Health status as evaluated by Quality of Life questionnaires
Time frame: Baseline (pre-procedure), 30-day, and 1-year
Valve thrombosis
Time frame: 30-day, 1-year, 3-year, and 5-year
Coronary obstruction requiring intervention
Time frame: Pre-discharge
Valve malpositioning
Time frame: Pre-discharge
Conversion to open surgery
Time frame: Pre-discharge
Unplanned use of mechanical circulatory support (cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), transcatheter pumps or intra-aortic balloon pump (IABP)
Time frame: Pre-discharge
Implantation of multiple (>1) transcatheter valves during the index hospitalization
Time frame: Index-procedure
Cardiac structural complications
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Ventricular septal perforation
Time frame: Pre-discharge
New onset of atrial fibrillation or atrial flutter
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Technical success
Time frame: Post-procedure
Myocardial Infarction
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Endocarditis
Time frame: 30-day, 1-year, 3-year, and 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 38369219Tobe 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.
- Results publication: PubMed 38795719Baumbach 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.
- Results publication: PubMed 39589296Royen 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.
- Results publication: PubMed 41079007Hasabo EA, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, IJsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Ninios V, Protasiewicz M, W M Rensing BJ, Martin PL, Feres F, 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, Van den Branden BJL, Thakkar A, Chandra U, Ayhan C, Neiroukh D, Nosir MY, Yacoub MS, Ali S, Altamimi M, Elzomor H, Serruys PW, Baumbach A, Soliman O. Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial. Int J Cardiol Heart Vasc. 2025 Sep 29;61:101804. doi: 10.1016/j.ijcha.2025.101804. eCollection 2025 Dec.
- Results publication: PubMed 41384893Serruys PW, Tobe A, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, Van den Branden BJL, 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, Abdel-Wahab M, Kristic I, Peral V, Garg S, Tsai TY, Thakkar A, Chandra U, Smits PC, Morice MC, Onuma Y, Baumbach A; LANDMARK Investigators. 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial. J Am Coll Cardiol. 2026 Feb 3;87(4):362-381. doi: 10.1016/j.jacc.2025.10.076. Epub 2025 Nov 16.
- Derived from this study: PubMed 42701683Tobe A, Onuma Y, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, van den Branden BJL, 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, Abdel-Wahab M, Kristic I, Peral V, Garg S, Thakkar A, Chandra U, Smits PC, Morice MC, Baumbach A, Serruys PW. Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial. Struct Heart. 2026 Jul 24;10(9):101101. doi: 10.1016/j.shj.2026.101101. eCollection 2026 Sep.
- Derived from this study: PubMed 40875489Soliman O, Hasabo EA, van Royen N, Amat-Santos IJ, Hudec M, Bunc M, IJsselmuiden A, Laanmets P, Unic D, Merkely B, Hermanides RS, Mouden M, Ninios V, Protasiewicz M, Rensing BJWM, Martin PL, Feres F, Almeida MS, van Belle E, Linke A, Ielasi A, Montorfano M, Webster M, Toutouzas K, Teiger E, Bedogni F, Voskuil M, Rubio DM, Angeras O, Kim WK, Rothe J, Kristic I, Peral V, Van den Branden BJL, Thakkar A, Chandra U, Neiroukh D, Ayhan C, Nosir MY, Yacoub MS, Ali S, Altamimi M, Elzomor H, Serruys PW, Baumbach A. Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial. Eur Heart J Cardiovasc Imaging. 2026 Feb 9;27(2):247-260. doi: 10.1093/ehjci/jeaf245.
- Derived from this study: PubMed 33833944Kawashima 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.
- Derived from this study: PubMed 33160946Kawashima 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.
- Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trialLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis. EuroInterventionLink provided by the sponsor.
- LANDMARK trial: Update in study protocol.Link provided by the sponsor.
- 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Baumbach, MD,FESC,FRCP study chair
Barts Heart Center, London, UK
Patrick W. Serruys, MD,PhD,FACC,FESC study director
National University of Ireland, Galway, Ireland
54 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myval THV Series and Contemporary Valves (Sapien THV Series and Evolut THV Series) in people with Aortic Valve Stenosis, run by Meril Life Sciences Pvt. Ltd. at 54 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, Italy, Netherlands, France, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashok Thakkar, PhD (+91-9879443584, ashok.thakkar@merillife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3) (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275726, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.