Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moder… (NCT07532317) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis
778 participantsStarted 2026-05-17
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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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
✓.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)
✓. Moderate AS participants with symptoms:
✓. Evidence of symptoms:
Exclusion criteria
✕. 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.