IRB Study Number 16-611
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
A prospective, single-arm, multicenter study to investigate the safety and effectiveness of SAPIEN 3/ SAPIEN 3 Ultra transcatheter heart valve (THV) implantation in patients with a failing aortic bioprosthetic valve
Inclusion Criteria
- Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm
- NYHA Functional Class ≥ II
- Other inclusion criteria will be assessed by study staff
Exclusion Criteria
- Surgical or transcatheter valve in the mitral position
- Severe regurgitation or stenosis of any other valve
- Failing valve has moderate or severe paravalvular regurgitation
- Other exclusion criteria will be assessed by study staff
