A Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Mitral Bioprosthetic Valve


About this study

The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mohamad Adnan Alkhouli, M.D.

Closed for enrollment

Contact information:

Amanda Biddle M.S.N., R.N.

(507) 538-5428


More information


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