LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Key facts
- Who runs it
- Meril Life Sciences Pvt. Ltd.
- Where
- Gothenburg and Uppsala, SwedenSee the 2 sitesAlso in 16 other countries, 52 sites
- Trial code
- Status
- Recruiting
- People taking part
- 988 people, planned
- Started
- 4 Nov 2020
- Expected to end
- 31 Dec 2033
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Myval THV Series
- Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Record updated
- 17 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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 take part
- Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study
- Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study
Where in Sweden
Also in 16 other countries, 52 sites
- Sahlgrenska University HospitalGothenburg, SwedenContact: Dr. Oskar AngreasTaking people
- Uppsala University HospitalUppsala, SwedenContact: Prof. Stefan JamesTaking people
About the trial
What the trial wants to find out
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 full original descriptionShow less
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)
The 4 groups in the trial
- Myval THV SeriesTreatment being tested
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.
- Contemporary ValvesExisting treatment, for comparison
* 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.
Treatment: Contemporary Valves (Sapien THV Series and Evolut THV Series)
- Myval THV Series XL Nested RegistryTreatment being tested
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
Treatment: Myval THV Series
- Myval THV Series Lead-in SetTreatment being tested
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.
Treatment: Myval THV Series
Results explained
A paper that names this trial, explained in plain words.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Publications
- Cardiac Damage and Clinical Outcomes in Symptomatic Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.JACC. Cardiovascular interventions, 2026
- Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial.Structural heart : the journal of the Heart Team, 2026
- 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial.Journal of the American College of Cardiology, 2026
- Record updated
- 17 August 2026