Ensayos clínicos

Inclusion Criteria:

• Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
• NYHA Functional Class ≥ II.
• Heart Team agrees that the patient is at intermediate surgical risk.
• 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.

Exclusion Criteria:

• 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).
• Aortomitral angle <105°.
• Severe regurgitation or stenosis of any other valve.
• Severe right ventricle (RV) dysfunction.