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Study of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve
The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing transcatheter aortic bioprosthetic valve.
In order to participate you must meet the following criteria:
- Have failing transcatheter aortic bioprosthetic valve with ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Have bioprosthetic valve with an internal orifice diameter of 16mm to 27mm.
- Have NYHA Functional Class ≥ II.
You will be excluded from the study if any of the following criteria apply to you:
- Have any paravalvular leak (PVL) in the aortic bioprosthetic valve.
- Need any concomitant revascularization for coronary artery disease (CAD).
- Have EF < 30% and eGFR < 30.
- Have severe regurgitation (>3+) or stenosis of any other valve.
This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided.