Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.

Inclusion Criteria:

• Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time)
• Legal age
• Signed informed consent prior to surgery
• Willing to complete all follow-up requirements

Exclusion Criteria:

• Pregnant or nursing women
• Already have had a valve replaced other than that for the scheduled replacement
• Needs another valve replaced
• Cannot return for required follow-up visits
• Have active endocarditis
• Acute preoperative neurological event (such as a stroke)
• Renal dialysis
• History of substance abuse within one year or is a prison inmate
• Participating in another study
• Had the Biocor or Biocor Supra valve implanted but then the device was explanted
• Life expectancy less than five years