Aortic Valve Replacement With Trifecta(TM)

An Observational, Prospective Evaluation of the Trifecta Valve

To confirm the clinical safety and effectiveness of the Trifecta valve.

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Inclusion Criteria:

• Requires aortic 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.
• Have already had a valve replaced other than the aortic valve.
• 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 a prison inmate.
• Participating in another study.
• Life expectancy less than two years.