Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR

Inclusion criteria

• . Patient above 18 years of age.
• . Patients must have co-morbidities such that the heart team and Investigator concur that the predicted risk of operative mortality is high.
• . Patient has non- or mild-calcified aortic regurgitation, undergoing TAVI with Myval THV Series without any degree stenosis, and severe aortic regurgitation as per investigator/ Heart team discretion according to (at least one) imaging criteria that can include:
• . Echocardiographically derived criteria: regurgitant volume ≥60 ml/beat, regurgitant fraction ≥50%, effective regurgitant orifice ≥0.3cm2, holodiastolic flow reversal at the level of the mid-descending aorta with an end diastolic flow velocity greater than 20 cm/s, width of vena contracta ≥6mm, hemi pressure time \<200 msec, or vena contracta area assessed with 3D echo ≥0.4 cm².
• . Cardiac magnetic resonance derived criteria: Regurgitant fraction \>40% or regurgitant volume \>60mL.
• . Patient suitable for implantation with Myval THV series via transfemoral approach.
• . Patient is symptomatic from his/her aortic valve regurgitation, as demonstrated by the New York Heart Association (NYHA) Functional Class ≥II.
• . Patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee of the respective clinical site.

Exclusion criteria