Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Status: Enrolling_by_invitation
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Symptomatic subjects with severe native aortic valve stenosis
• aortic valve annulus mean diameter ≤23 mm
• Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
• Institutional heart team determines that TAVR is appropriate
• Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Locations
United States
Arizona
Banner - University Medical Center, Phoenix campus
Phoenix
Tucson Medical Center
Tucson
Florida
Delray Medical Center
Delray Beach
Time Frame
Start Date: 2020-05-12
Completion Date: 2025-06
Participants
Target number of participants: 150
Treatments
Active_comparator: Supra-Annular transcatheter heart valve
Medtronic Evolut Pro Valve implantation
Active_comparator: Annular transcatheter heart valve
Edwards Sapien 3 Ultra implantation
Authors
Related Therapeutic Areas
Sponsors
Collaborators: William Beaumont Hospitals
Leads: Marvin Eng