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

Starting soon · Not applicable

Conditions studied: Moderate Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07532317

Run by

Meril Life Sciences Pvt. Ltd.

People needed

778

Starts

2026-05-17

Expected to finish

2041-05-12

Last updated by the study team

2026-05-06

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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.

Full record on ClinicalTrials.gov

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