View important safety information regarding the commercial TAVR device used in the trial by visiting the link below.
The purpose of the EXPAND TAVR II Pivotal Trial is to explore the treatment of moderate aortic stenosis (AS) with early transcatheter aortic valve replacement (TAVR) before AS becomes severe. Early treatment of AS may help preserve cardiac function, prevent or slow further deterioration in cardiac function, and prevent death in some patients.
~650 randomized subjects
Australia, Canada, Europe, Israel, Japan, New Zealand, and United States
10 years of follow-up
Multicenter, international, prospective, randomized
Visit clinicaltrials.gov for more information about the EXPAND TAVR II Pivotal Trial.
Use identifier number NCT05149755 to see details on the EXPAND TAVR II Pivotal Trial.
Please visit clinicaltrials.gov for complete list of patient selection criteria.
Patients presenting with LVEF < 50%, AVA of ≤ 1.0 cm2, and mean gradient ≥ 20 mm Hg and < 40 mm Hg at rest may undergo low-dose DSE to assess if subject has moderate AS versus low-flow, low-gradient severe AS.
More details available in clinical investigational plan from Medtronic.
Strange G, Stewart S, Celermajer D, et al. Poor Long-Term Survival in Patients With Moderate Aortic Stenosis. J Am Coll Cardiol. October 15, 2019;74(15):1851-1863.