ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

• Migration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Migration is defined as complete or partial displacement (tilting) of the device from its original locus resulting in coronary ostia blockage, perivalvular leak, or incompetence.
• Thromboembolism/Thrombosis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Valve related thromboembolism and valvular thrombosis.
• Hemorrhage (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  All bleeding events regardless of whether or not the event is related to anticoagulation therapy and will be categorized as minor and major events.
• Perivalvular Leaks (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  All perivalvular leak events will be reported.
• Endocarditis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Study valve endocarditis.
• Hemolysis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Hematology/Chemistry data will be analyzed to determine if significant subclinical or unreported hemolysis is occuring.
• Structural Valve Deterioration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Structural valve deterioration data will be collected.
• Non-Structural Dysfunction [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Perivalvular Leak, Hemolysis, Entrapment by pannus, tissue or suture, Inappropriate sizing or positioning, and Distortion.
• Re-operation, Explant, Death (all Deaths and valve related) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  Re-operations, Explant, and Death (all Deaths and valve related)

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.

Inclusion Criteria:

• The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
• The patient is geographically stable and willing to return to the implant site for follow-up visits.
• The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
• If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.

Exclusion Criteria:

• The patient requires replacement of two or more valves.
• The patient is < 20 years of age.
• The 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 24 months.
• The patient is an intravenous drug and/or alcohol abuser.
• The patient presents with active endocarditis or other systemic infection.
• The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
• The patient is participating in concomitant research studies of investigational products.
• The 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.
• The patient has chronic renal failure.