The PARTNER 3 - AVIV Trial

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.

Inclusion Criteria:

1. Failing surgical or transcatheter bioprosthetic valve in the aortic position
demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

2. Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.

3. NYHA Functional Class ≥ II.

4. Heart Team agrees valve implantation will likely benefit the patient.

5. 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.

Exclusion Criteria:

1. Surgical or transcatheter valve in the mitral position (mitral rings are not an
exclusion).

2. Severe regurgitation (>3+) or stenosis of any other valve.

3. Failing valve has paravalvular regurgitation (includes those instances that have been
previously treated with a plug due to paravalvular regurgitation).

4. Failing valve is unstable, rocking, or not structurally intact.

5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.

6. Increased risk of embolization of THV (e.g., surgical valve that is non-stented and
non-calcified).

7. Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index
procedure for implantation of the original valve.