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.
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
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).