Aortic Valve Replacement With Trifecta(TM)

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.