A Randomized Study Comparing the DurAVR Biomimetic Valve to Approved TAVR Devices for Treating Severe Aortic Stenosis

What this Trial Is About

Researchers are conducting a prospective, randomized, controlled, international study involving up to 1054 adults with severe native calcific aortic stenosis who need Transcatheter Aortic Valve Replacement TAVR. The trial aims to compare the DurAVR4 THV System with commercially available Transcatheter Heart Valves from the SAPIEN or Evolut series. Additionally, up to 446 low-risk subjects will be enrolled in a continued access cohort, and a separate registry will follow 150 subjects with failed surgical bioprosthetic valves requiring valve-in-valve TAVR using the DurAVR4 THV. Participants will be randomized to receive either the DurAVR4 THV System or a commercially approved SAPIEN or Evolut THV device for native aortic stenosis. Those in the valve-in-valve registry cohort will receive only the DurAVR4 THV. Subjects will be followed for up to 10 years in the randomized cohorts and 5 years in the valve-in-valve registry. The study involves device implantation through TAVR procedures performed under clinical guidelines. During the study, participants will be monitored for outcomes including a composite of all-cause mortality, stroke, and cardiovascular hospitalization after one year. Secondary measures include mortality, disabling stroke, bleeding, vascular complications, and acute kidney injury within 30 days post-procedure. Follow-up visits and assessments will track participant health and device performance over the long term to evaluate safety and effectiveness.

A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System