START YOUNG

START YOUNG is a groundbreaking, investigator-initiated, prospective, multicenter, randomized trial comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) using the balloon-expandable Myval THV in patients aged 65 to 75 years with symptomatic severe aortic stenosis.

Its primary objective is to demonstrate the non-inferiority of TAVR compared to SAVR in terms of:

• Safety at 30 days, defined as a Composite of all-cause death, any stroke, BARC 3 to 5 bleeding, AKI stage 2-4 (VARC-3 definition), rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction (VARC-3 definition)
• Efficacy at 1 year, defined as a Composite of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition) 
  Secondary endpoints include long-term outcomes up to 5 years.

The START YOUNG study includes a CT scan subgroup. The purpose is to assess anatomical suitability for future redo-TAVR or valve-in-valve procedures, supporting long-term management planning.
By directly comparing SAVR and TAVR in a younger population—where long-term durability and reintervention options are critical—START YOUNG addresses a major evidence gap and will provide essential data to guide future treatment strategies and lifetime valve management.
The study will enroll 1,180 patients across approximately 60 centers worldwide, randomized 1:1 between SAVR and TAVR.