Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Myval balloon-expandable THV Series: Patients receive Myval balloon-expandable THV Series (TAVR)

Surgical bioprosthetic valve: Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

Study summary

The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.

Eligibility

Primary outcome measure(s)

• Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction. — 1 month post procedure
  Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.
• Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event — 1 year post procedure
  Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)
• CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases). — 1 month post procedure
  Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.

Trial sites (49)

+ 9 more sites — see the full list on the official registry below.