ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled
patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days
(whichever comes last), 3-6 month, and annual follow-up data are required.

Inclusion Criteria:

- Patient is without concomitant procedures such as coronary artery bypass or another valve
reconstruction. (The three remaining valves must be of native tissue).

- Patient is sufficiently ill to warrant replacement of his/her diseased natural or
prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000
bioprosthesis), based on standard cardiovascular diagnostic workups.

- Patient is in satisfactory condition, based on the physical exam and Investigator's
experience, to be an average or better operative risk, (i.e., likely to survive three
years postoperatively).

- Patient is geographically stable and willing to return to the implant center for
follow-up visits.

- Patient has been adequately informed and consents to his/her participation in the
clinical study, and of what will be required of him/her, in order to comply with the
protocol.

Exclusion Criteria:

- Patient is older than seventy (70) years of age.

- Patient has a non-cardiac major or progressive disease, which in the Investigator's
experience produces an unacceptable increased risk to the patient, or results in a
life expectancy of less than 3 years.

- Patient is an intravenous drug and/or alcohol abuser.

- Female patient is pregnant (urine HCG test result positive), or lactating.

- Patient presents with active endocarditis.

- Patient presents with congenital bicuspid aortic anatomy.

- This patient presents with abnormal aortic root geometry.

- Patient has chronic renal failure or is on renal dialysis.

- Patient has a previously implanted prosthetic valve that is not being replaced by a
study valve.

- Patient requires mitral, tricuspid or pulmonic valve replacement.

- Patient presents with dilatation of the ascending aorta, Marfan Syndrome,
Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the
ascending aorta to be irregular in geometry or physiology as seen via preoperative
imaging.

- Patient is participating in concomitant research studies of investigational products.

- Patient will not agree to return to the implant center for the required number of
follow-up visits or is geographically unavailable for follow-up.