A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Edwards Lifesciences
Summary
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Description
This is a prospective, single-arm, multicenter study.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency. 2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm. 3. NYHA Functional Class ≥ II. 4. Heart Team agrees the patient is low to intermediate risk. 5. Heart Team agrees valve implantation will likely benefit the patient. 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Surgical or transcat…
Interventions
- DeviceEdwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Locations (51)
- Banner University Medical CenterPhoenix, Arizona
- University of California Los AngelesLos Angeles, California
- Sutter Medical CenterSacramento, California
- Kaiser Permanente San FranciscoSan Francisco, California
- Stanford University Medical CenterStanford, California
- UC Health Northern Colorado/Medical Center of the RockiesLoveland, Colorado