Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Inclusion Criteria:

• The patient is male or female 18 years old or older.
• The patient is willing to sign the informed consent.
• The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
• Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
• The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
• Patient will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria:

• The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
• The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
• The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
• The patient has active endocarditis.
• The patient is or will be participating in a concomitant research study of an investigational product.
• The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
• The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
• The patient is pregnant or lactating.
• Patients with congenital bicuspid aortic valve.
• Patients are known to be noncompliant or are unlikely to complete the study.