On-X Heart Valve - 17mm Aortic and 23mm Mitral

Exclusion Criteria

• •1\. Patients who are pregnant, planning to become pregnant or are lactating. 2 Patients who have a noncardiac progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient.
• •3 Patients who have a documented history of substance (drug or alcohol) abuse or are prison inmates.
• •4\. Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement.
• •5\. Patients with active endocarditis or active myocarditis. 6 Patients who require tricuspid or pulmonic valve replacement. 7. Patients who have not agreed to return for the required number of follow-up visits or who are geographically unavailable for follow-up.
• •8\. Patients who cannot be maintained on long-term anticoagulant therapy. 9. Patients with non-cardiac illness resulting in a life expectancy of less than 1-year.
• •10\. Patients previously enrolled and implanted in this trial may not re-enter after withdrawal.
• •11\. Patients already enrolled in another investigational device or drug study (nor can enrolled patients be enrolled in other studies).
• •12\. Patients with acute preoperative neurological deficit, myocardial infarction, or cardiac event who have not returned to baseline for at least 30-days prior to enrollment.
• •13\. Patients with aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complication.
• •14\. Patients who are prisoners or mentally ill, and pediatric patients who are incapable of understanding their assent as judged by the principal investigator.