The PARTNER 3 - AVIV Trial
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.
- Aortic Stenosis
- Cardiomyopathy, Hypertrophic
- Eligible Ages
- Over 19 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
- NYHA Functional Class ≥ II.
- Heart Team agrees valve implantation will likely benefit the patient.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
- Severe regurgitation (>3+) or stenosis of any other valve.
- Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
- Failing valve is unstable, rocking, or not structurally intact.
- Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
- Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
- Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Failing surgical valve
|Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.||
Failing transcatheter valve
|Patients with a failing transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.||
- Edwards Lifesciences
Study ContactJustine Encabo
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency.