Autus Valve Pivotal Study

Eligibility Criteria

• 1. Age 18 months to 16 years.
• 2. Male or female.
• 3. Subject has a native or repaired right ventricular outflow tract.
• 4. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
• 5. Subject has at least one of the following echocardiographic findings:
• 1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
• 2. Moderate or greater pulmonary regurgitation;
• 3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
• 6. Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
• 7. Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
• 8. Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.
• 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 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 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 leukopenia (defined as a white blood cell (WBC) count \<3.5 x 103/µL)
• 10. Subject has acute or chronic anemia (defined as hemoglobin (Hgb) \<10.0 g/dl or 6 mmol/L).
• 11. Subject has thrombocytopenia (defined as platelet count \<50 x 103/µL.
• 12. Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.
• 13. Subject has a known autoimmune disease or receives immunosuppressant and/or immunostimulant drugs that 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.