PARTNER 3 Trial - Mitral Valve in Valve

A prospective, single-arm, multicenter clinical trial. This study will enroll patients with
symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed,
insufficient, or combined).

Inclusion Criteria:

1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating
≥ moderate stenosis and/or ≥ moderate insufficiency.

2. NYHA Functional Class ≥ II.

3. Heart Team agrees that the patient is at intermediate surgical risk.

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. Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is
not securely fixed in the native annulus or is not structurally intact as determined
by transesophageal echocardiography (TEE).

2. Aortomitral angle <105°.

3. Severe regurgitation or stenosis of any other valve.

4. Severe right ventricle (RV) dysfunction.