Clinical Investigation of the Freedom SOLO Stentless Heart Valve

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.