Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis

NCT07532317 | Not Yet Recruiting DMC

• 1 other identifier: MLS/MYV/LANDMARK 2
• Study Type: interventional
• Target: 778
• Locations: 17 countries
• Sites: 59

Brief 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.

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; Myval THV; Myval Octacor THV; Myval OctaPro THV; Myval OctaPro+ THV

Outcome Measures

Primary Outcomes (1)

• 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.

  2-year

Secondary Outcomes (24)

• All-cause mortality

  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

  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)

  Pre-discharge, 30-day

• Bleeding (Type 2, 3 and 4)

  Predischarge, 30-day

• Major vascular complications

  30-day

Study Arms (2)

Guideline-directed medical therapy

NO INTERVENTION

Transcatheter Aortic Valve Implantation

EXPERIMENTAL

Device: Transcatheter aortic valve Implantation

Interventions

Transcatheter aortic valve Implantation DEVICE

Myval THV Series will include Myval/Myval Octacor/ OctaPro/OctaPro+ THV or any subsequent advanced version commercially available at the investigator site.

Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• The participant must meet one of the following categories:
• AVA \> 1.0 - ≤ 1.5 cm²; OR
• AVA ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²)
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Dr.Ashokkumar Thakkar, PhD. Clinical Pharmacology

CONTACT

+91-9879443584; landmark.2@merillife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): May 12, 2031
• Study Completion (Estimated): May 12, 2041
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7); BR (1); AU (3); ZA (1); FR (13); CH (1); GB (1); ES (13); DE (6); NO (1); SL (1); IT (3); BE (1); SE (1); DK (2); FI (2); NZ (2)