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

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Diseased Heart Valve, Replacement, Aortic, Stentless Read More

Inclusion Criteria:

• Patient is </= 70 years of age and requires isolated aortic valve replacement with or 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.