Moderate Aortic StenosisNCT07532317
Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis
A study testing Transcatheter aortic valve Implantation in people with Moderate Aortic Stenosis, run by Meril Life Sciences Pvt. Ltd..
Trial summary
The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Moderate Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2026to 12 May 2041
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All participants for this study must meet all of the following inclusion criteria:
- Participants with ≥ 65 years of age.
- Participant has provided written informed consent as approved Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) of the investigational site to participate in the study.
- Participant with moderate aortic stenosis, defined as one of the following
- Peak aortic jet velocity (Vmax) ≥ 3.0 m/s and < 4.0 m/s, or
- Mean pressure gradient ≥ 25 mmHg and < 40 mmHg AND
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- The participant must meet one of the following categories:
- 3.1.AVA > 1.0 - ≤ 1.5 cm²; OR
- 3.2.AVA ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)
- 3.2.1 Left Ventricular Function and Flow Profile: It is defined as participants with peak aortic jet velocity (Vmax) ≥ 3.0 and < 4.0 m/s or mean pressure gradient ≥ 25 and < 40 mmHg, and in the presence of aortic valve area (AVA) ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)
- The participant must meet one of the following categories:
- a.Normal-Flow, Preserved LVEF:
- Stroke Volume Index (SVi > 35 ml/m²) and LVEF ≥ 50% then, perform CT aortic valve calcium score to confirm true moderate AS:<1200 AU (female) or < 2000 AU (male) OR b.Low-Flow, Preserved LVEF:
- SVi ≤ 35 ml/m² and LVEF ≥ 50%, then perform CT aortic valve calcium score to confirm true moderate AS: < 1200 AU (female) or < 2000 AU (male) OR c.Low-Flow, Reduced LVEF:
- SVi ≤ 35 ml/m² and LVEF < 50%, then confirm contractile reserve on dobutamine stress echocardiography (DSE)^, defined as a ≥ 20% increase in stroke volume with; I.AVA > 1.0 and ≤ 1.5 cm² or II.AVA > 1.0 cm² then perform CT aortic valve calcium score to confirm true moderate AS: < 1200 AU (female) or < 2000 AU (male) ^ If DSE is not feasible or inconclusive, CT calcium scoring will be considered, with thresholds of < 1200 AU for female and < 2000 AU for male to identify Moderate AS participants.
- Not applicable for asymptomatic participants as asymptomatic with SVi > 35 are excluded.
- Moderate AS participants with symptoms:
- Evidence of symptoms:
- I.NYHA class ≥ II# and II.Chronic Dyspnea or III.Angina (CCS ≥ II) or IV.Cardiac Syncope
- OR
- Asymptomatic moderate AS participants with at least one of the evidence of cardiac damage/dysfunction:
- I.Participant with left ventricle ejection fraction ≤ 50% or
- II.Diastolic dysfunction ≥ Grade II or
- III.Stroke Volume Index ≤ 35 ml/m² or
- IV.Persistent Atrial Fibrillation (AF) lasting from past 6 months or Paroxysmal Atrial Fibrillation episode within 6 months prior to consent or
- V.NT-proBNP ≥ 200 pg/ml or ng/l or ≥ 200000 µg/l (or BNP ≥ 50 pg/ml or ng/l or ≥ 50000 µg/l) or
- VI.LV mass index > 95 g/m² for female and > 115 g/m² for male (To detect LV hypertrophy) or
- VII.LV dimension or
- LV systolic diameter > 4 cm or > 40 mm for male and > 3.5 cm or 35 mm for female or
- LV diastolic diameter > 5.8 cm or > 58 mm for male and > 5.2 cm or 52 mm for female
- VIII.LV volume
- LV systolic volume > 61 mL or cm3 for male and > 42 mL or cm3 for female or
- LV diastolic volume > 150 mL or cm3 for male and > 106 mL or cm3 for female
- Only 10% of total study participants with NYHA class IV will be included in the trial.
Who cannot join
- Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve.
- Aortic valve is unicuspid or non-calcified as verified by echocardiography/CT.
- Renal insufficiency with glomerular filtration rate (GFR) < 30 mL/min and/or need for renal replacement therapy.
- Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade).
- Participants with severe aortic stenosis.
- Moderate or severe mitral/tricuspid regurgitation (≥ 3 grade).
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- Participants with pre-existing mechanical or bioprosthetic aortic valve.
- Left ventricle ejection fraction ≤ 20%.
- Severe left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVI.
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- Previous stroke with permanent disability (modified Rankin score ≥ 2).
- Life expectancy < 24 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease.
- Currently participating in an investigational drug or another device study where the primary endpoint is not achieved.
- Any condition, which in the Investigator's opinion, would preclude safe participation of participants in the study (e.g. psychiatric, alcoholism).
- TAVI unsuitable via transfemoral route.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared to Guideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.
The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.
Read the detailed description
Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab.
- Conditions
- Moderate Aortic Stenosis
- Being tested
- Transcatheter aortic valve Implantation
- Keywords
- Cardiac Damage, Effectiveness, Guideline Directed Medical Therapy, Left ventricular ejection fraction, Low-flow, low-gradient aortic stenosis, Transcatheter Heart Valve THV), Moderate aortic stenosis, Myval THV series, Myval THV, Myval Octacor THV, Myval OctaPro THV, Myval OctaPro+ THV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve ImplantationDevice
Myval THV Series will include Myval/Myval Octacor/ OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site.
| Study group | Role | What they receive |
|---|---|---|
| Guideline-directed medical therapy | No intervention | Not described |
| Transcatheter Aortic Valve Implantation | Experimental | Not described Receives: Device: Transcatheter aortic valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
It is the composite of following:
All-cause mortality,
Disabling stroke,
Aortic valve replacement due to advanced valve syndrome (AVS),
Heart failure hospitalization,
Deterioration in quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years or at the time of conversion to AVR in the GDMT arm.
Measured: 2-year
Secondary outcomes (24)
All-cause mortality
As per VARC-3 defined criteria
Measured: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year
All stroke
As per VARC-3 defined criteria
Measured: Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Acute Kidney Injury (AKI)
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day
Bleeding (Type 2, 3 and 4)
As per VARC-3 defined criteria
Measured: Predischarge, 30-day
Major vascular complications
As per VARC-3 defined criteria
Measured: 30-day
Conduction disturbances and arrhythmias
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5- year, 3-year and 5-year
New Permanent Pacemaker Implantation (PPI)
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Proportion of participants requiring initiation of Cardiac Resynchronization Therapy
Initiation of CRT (Cardiac Resynchronization Therapy Pacemaker or Defibrillator with Cardiac Resynchronization Therapy) as clinically indicated by the treating cardiologist.
Measured: Pre-discharge, 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement due to advanced valve syndrome
Measured: 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Myocardial Infarction
As per VARC-3 defined criteria
Measured: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year
New York Heart Association (NYHA) functional classification
Measured: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2- year, 2.5-year, 3-year and 5-year
Six-minute walk test
Measured: Screening, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Echocardiographic endpoints
Measured: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10- year
Bioprosthetic valve failure
VARC-3 defined criteria
Measured: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Bioprosthetic valve deterioration
VARC-3 defined criteria
Measured: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Aortic bioprosthetic valve dysfunction
As per VARC-3 defined criteria
Measured: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Heart failure hospitalization
As per VARC-3 defined criteria
Measured: 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Kansas City Cardiomyopathy Questionnaire
Overall Summary Score < 45 or decline from baseline of >10 point (Unfavorable Outcome)
Score Interpretation:
0 to 25: Very poor to poor health 25 to 49: Poor to fair health 50 to 74: Fair to good health 75 to 100: Good to excellent health
Measured: Screening, 1-year, 2-year, At time of conversion to AVR from GDMT arm
Moderate or severe prosthetic valve regurgitation
As per VARC-3 defined criteria
Measured: Screening, Pre-discharge, 30-day, 6-month, 1- year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) or BNP
Measured: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
New onset of atrial fibrillation or atrial flutter
As per VARC-3 defined criteria
Measured: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement or reintervention
Aortic valve replacement or reintervention is defined as any surgical or transcatheter procedure performed to replace the native aortic valve with a prosthetic valve or to treat dysfunction of a previously implanted prosthetic aortic valve. This includes surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI), valve-in-valve TAVI, redo TAVI, or surgical replacement of a previously implanted transcatheter or surgical valve.
Measured: 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Technical success
As per VARC-3 defined criteria
Measured: At exit from procedure room
Device success
As per VARC-3 defined criteria
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 May 2026 (estimated)
- Primary completion12 May 2031 (estimated)
- Study completion12 May 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Aortic 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
- Masking
- None (open label)
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532317
- Sponsor's protocol ID
- MLS/MYV/LANDMARK 2
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared to Guideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.
- ClinicalTrials.gov ID
- NCT07532317
- Acronym / sponsor ID
- MLS/MYV/LANDMARK 2
- Conditions
- Moderate Aortic Stenosis
- Keywords
- Cardiac Damage, Effectiveness, Guideline Directed Medical Therapy, Left ventricular ejection fraction, Low-flow, low-gradient aortic stenosis, Transcatheter Heart Valve THV), Moderate aortic stenosis, Myval THV series
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2026 (estimated)
- Primary completion
- 12 May 2031 (estimated)
- Study completion
- 12 May 2041 (estimated)
- First posted
- 15 Apr 2026 (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 trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.
Detailed description
Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline-directed medical therapy | No intervention | – |
| Transcatheter Aortic Valve Implantation | Experimental | Device: Transcatheter aortic valve Implantation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (34 listed)
- Participants with ≥ 65 years of age.
- Participant has provided written informed consent as approved Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) of the investigational site to participate in the study.
- Participant with moderate aortic stenosis, defined as one of the following
- 3.1.AVA > 1.0 - ≤ 1.5 cm²; OR
- 3.2.AVA ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)
Key exclusion criteria (15 listed)
- Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve.
- Aortic valve is unicuspid or non-calcified as verified by echocardiography/CT.
- Renal insufficiency with glomerular filtration rate (GFR) < 30 mL/min and/or need for renal replacement therapy.
- Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade).
- Participants with severe aortic stenosis.
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 |
|---|---|---|
| Transcatheter aortic valve ImplantationMyval THV Series will include Myval/Myval Octacor/ OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site. | Device | Transcatheter Aortic Valve Implantation |
Primary outcome
Primary Efficacy Endpoint
Time frame: 2-year
It is the composite of following: All-cause mortality, Disabling stroke, Aortic valve replacement due to advanced valve syndrome (AVS), Heart failure hospitalization, Deterioration in quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years or at the time of conversion to AVR in the GDMT arm.
24 secondary outcomes
All-cause mortality
Time frame: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year
All stroke
Time frame: Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Acute Kidney Injury (AKI)
Time frame: Pre-discharge, 30-day
Bleeding (Type 2, 3 and 4)
Time frame: Predischarge, 30-day
Major vascular complications
Time frame: 30-day
Conduction disturbances and arrhythmias
Time frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5- year, 3-year and 5-year
New Permanent Pacemaker Implantation (PPI)
Time frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Proportion of participants requiring initiation of Cardiac Resynchronization Therapy
Time frame: Pre-discharge, 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement due to advanced valve syndrome
Time frame: 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Myocardial Infarction
Time frame: Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year
New York Heart Association (NYHA) functional classification
Time frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2- year, 2.5-year, 3-year and 5-year
Six-minute walk test
Time frame: Screening, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Echocardiographic endpoints
Time frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10- year
Bioprosthetic valve failure
Time frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Bioprosthetic valve deterioration
Time frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Aortic bioprosthetic valve dysfunction
Time frame: 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Heart failure hospitalization
Time frame: 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Kansas City Cardiomyopathy Questionnaire
Time frame: Screening, 1-year, 2-year, At time of conversion to AVR from GDMT arm
Moderate or severe prosthetic valve regurgitation
Time frame: Screening, Pre-discharge, 30-day, 6-month, 1- year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) or BNP
Time frame: Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
New onset of atrial fibrillation or atrial flutter
Time frame: Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year
Aortic valve replacement or reintervention
Time frame: 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year
Technical success
Time frame: At exit from procedure room
Device success
Time frame: 30-day
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 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve Implantation in people with Moderate Aortic Stenosis, run by Meril Life Sciences Pvt. Ltd..
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 34 inclusion and 15 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dr.Ashokkumar Thakkar, PhD. Clinical Pharmacology (+91-9879443584, landmark.2@merillife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.