Evolut™ EXPAND TAVR II Pivotal Trial
Sponsor: Medtronic
This trial focuses on the safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the Medtronic Evolut™ PRO+/FX self-expanding transcatheter heart valve system in patients with symptomatic moderate aortic stenosis. This is a multicenter, international, prospective, randomized, open-label study that aims to enroll 650 participants. After an extensive screening phase and approval by an Eligibility Review Committee, subjects will be randomized to either TAVR and guideline-directed management (GDMT) or GDMT alone. The primary endpoint of this trial is a composite rate of all-cause mortality, heart failure events, and aortic valve replacement or re-intervention at 2 years.
Study team:
SI: C.S. Venema
Research Coordinator: Sanne Stuiver
Project Coordinator: Greetje de Jong