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

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.