An interventional study of Myval THV Series and Contemporary Valves (Sapien THV Series and Evolut THV Series) in Aortic Valve Stenosis, sponsored by Meril Life Sciences Pvt. Ltd.. Recruiting at 54 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Meril Life Sciences Pvt. Ltd. · Not applicable, Interventional, and Treatment
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)
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 988 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Meril Life Sciences Pvt. Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Myval 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.
Device: Contemporary Valves (Sapien THV Series and Evolut THV Series)
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
Device: Myval THV Series
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.
Device: 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.
Also known as: 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.
Also known as: 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.
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
Time frame: 30-day
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
Time frame: 1-year
All-cause mortality
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
All stroke
As per VARC-3 defined criteria
Time frame: 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
Time frame: Pre-discharge, 30-day, and 1-year
Bleeding (Type 3 and 4)
As per VARC-3 defined criteria
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Moderate or severe prosthetic valve regurgitation
As per VARC-3 defined criteria
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)
o New PPI rates will be analysed further based on the patient's history of left and/or right bundle branch block.
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
As per VARC-3 defined criteria
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Device success
As per VARC-3 defined criteria
Time frame: Pre-discharge and 30-day
Early safety at 30 days
As per VARC-3 defined criteria
Time frame: 30-day
Clinical efficacy at 30 days
As per VARC-3 defined criteria
Time frame: After 30 days of index procedure
Valve related long-term clinical efficacy
As per VARC-3 defined criteria
Time frame: 5-years, 7 years and 10 years
Vascular and access related complications
As per VARC-3 defined criteria
Time frame: Pre-discharge, 30-day, and 1-year
Major vascular complications
As per VARC-3 defined criteria
Time frame: 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 \[Time frame: Baseline (pre-procedure), 30-day and 1-year\]
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
* 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
Time frame: 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
Time frame: 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
Time frame: Pre-discharge, 30-day, and 1-year
Length of index hospital stay
o Number of days from hospital admission to discharge.
Time frame: At discharge
Re-hospitalization
As per VARC-3 defined criteria
Time frame: 30-day, 1-year, 3-year, and 5-year
Health status as evaluated by Quality of Life questionnaires
o 12-Item Short Form Survey (SF-12)
Time frame: Baseline (pre-procedure), 30-day, and 1-year
Valve thrombosis
o 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.
Time frame: 30-day, 1-year, 3-year, and 5-year
Coronary obstruction requiring intervention
As per VARC-3 defined criteria
Time frame: Pre-discharge
Valve malpositioning
As per VARC-3 defined criteria
Time frame: Pre-discharge
Conversion to open surgery
As per VARC-3 defined criteria
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)
As per VARC-3 defined criteria
Time frame: Pre-discharge
Implantation of multiple (>1) transcatheter valves during the index hospitalization
As per VARC-3 defined criteria
Time frame: Index-procedure
Cardiac structural complications
As per VARC-3 defined criteria
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Ventricular septal perforation
o Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure
Time frame: Pre-discharge
New onset of atrial fibrillation or atrial flutter
As per VARC-3 defined criteria
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Technical success
As per VARC-3 defined criteria
Time frame: Post-procedure
Myocardial Infarction
As per VARC-3 defined criteria
Time frame: Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Endocarditis
As per VARC-3 defined criteria
Time frame: 30-day, 1-year, 3-year, and 5-year
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Plan to share: No
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