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.
Sponsor
CERC Services
- Clinical trial documentation
- Regulatory submissions
- Sites Contracts & Fees management
- Project management
- Electronic Data Capture Management
- Monitoring activities
- CEC activities
- Core Laboratory
- CEC and DSMB activities
- Safety reporting
- Statistical Activities
- Clinical report
Countries
60 investigational sites all around the world in :
Austria, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Poland, Portugal, Serbia, Slovenia, Spain, Sweden, Switzerland, UK
