Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

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.

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

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).

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.

Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time

Number of participants who experience all-cause mortality at each follow-up time point.

Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time

Number of participants with any stroke (ischemic or hemorrhagic) as defined by clinical assessment and imaging confirmation.

Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time

Number of participants experiencing bleeding events classified as VARC-3 type 1 (BARC 3a), type 2 and 3. * Scoring System: Valve Academic Research Consortium (VARC) scale: * 1 * Overt bleeding not requiringing surgical or percutaneous intervention, but requiring medical intervention, leading to hospitalization, an increased level of care, or medical evaluation * Overt bleeding requiring a transfusion of 1 unit of whole blood/RBC * 3 * Overt bleeding in a critical organ, such as intracranial, intraspinal, intraocular, pericardial or intramuscular with compartment syndrome * Overt bleeding causing hypovolemic shock or severe hypotension * Overt bleeding requiring reoperation, surgical exploration, or re-intervention for the purpose of controlling bleeding * Post-thoracotomy chest tube output ≥2 L within 24-h * Overt bleeding requiring a transfusion of ≥5 units of whole blood/RBC * Overt bleeding associated with a haemoglobin drop ≥5 g/dL * Higher scores indicate worst outcomes

Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time

Number of participants with acute kidney injury (AKI) stage 2-4 based on VARC-3 * Scale Information: AKI from Valve Academic Research Consortium 3 (VARC-3): * Scoring System: * Stage 1: AKI that fulfils at least one of the following criteria: * Increase in serum creatinine ≥150-200% (≥1.5-2.0x increase) within 7 days compared with baseline * Increase of ≥ 0.3mg/dL (≥26.4 μmol/L) within 48 h of the index procedure o Stage 2: AKI that fulfils the following criterion: * Increase in serum creatinine \>200-300% (\>2.0-3.0x increase) within 7 days compared with baseline o Stage 3: AKI that fulfils at least one of the following criteria: * Increase in serum creatinine \>300% (\>3.0x increase) within 7 days compared with baseline * Serum creatinine ≥4.0 mg/dL (≥354 μmol/L) with an acute increase of ≥0.5 mg/dL (≥44 μmol/L) * Stage 4: AKI requiring new temporary or permanent renal replacement therapy * Interpretation: Higher stages indicate more severe kidney injury