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

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

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