Autus Valve Continued Access Study (CAS)

Exclusion Criteria

• •1. Subject requires valve replacement in a non-pulmonary position.
• •2. Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).
• •3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
• •4. Subject has a known history of pulmonary atresia and major aortopulmonary collaterals.
• •5. Subject has significant peripheral pulmonary artery stenosis.
• •6. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
• •7. Subject has active endocarditis or a history of infective endocarditis.
• •8. Subject has a known history of renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renal disease.
• •9. Subject has a known history of leukopenia (defined as a white blood cell \[WBC\] count \<3.5 x 103/µL).
• •10. Subject has a known history of acute or chronic anemia (defined as hemoglobin \[Hgb\] \<10.0 g/dl or 6 mmol/L).
• •11. Subject has a known history of thrombocytopenia (defined as platelet count \<50 x 103/µL).
• •12. Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs.
• •13. Subject has a known history of autoimmune disease or receives immunosuppressant and/or immunostimulant drugs, and the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.
• •14. Subject needs emergency cardiac or vascular surgery or intervention.
• •15. Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
• •16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
• •17. Subject or parent/legal representative refuses blood transfusions.
• •18. Subject has medical, social, or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
• •19. Subject is participating in an investigational study of a new drug, biologic, or device at the time of study screening.
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