Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in
subjects who had a Trifecta valve implanted during the IDE study.

Inclusion Criteria:

- Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.

- Subject met eligibility criteria of IDE study

- Subject agrees to complete study follow-up visits

- Subject provides written informed consent

Exclusion Criteria:

- Subject currently participating in another device or drug study

- Subject unable or unwilling to return for study follow-up visits