Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Prior treatment

• The patient is an intravenous drug abuser.
• The patient is currently participating in a study of an investigational drug or device.
• The patient was previously enrolled in the study.
• The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.

Other illness

• The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.

Other

• The patient presents with active endocarditis within the last 3 months.
• The patient is pregnant or lactating.
• The patient is currently a prison inmate.
• The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
• The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)\*.

• The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
• The patient has signed and dated the subject informed consent form prior to surgery.
• The patient is expected to survive the surgery and be discharged.
• The patient is geographically stable and agrees to attend follow-up assessments.
• The patient is 18 years or older.