Autus Valve Continued Access Study (CAS)

Inclusion criteria

• Age 18 months to 16 years.
• Male or female.
• Subject has a native or repaired right ventricular outflow tract.
• Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
• Subject has at least one of the following echocardiographic findings:
• Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
• Moderate or greater pulmonary regurgitation;
• Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
• Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
• Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
• 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.

Exclusion criteria

• Subject requires valve replacement in a non-pulmonary position.
• 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).
• Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
• Subject has a known history of pulmonary atresia and major aortopulmonary collaterals.
• Subject has significant peripheral pulmonary artery stenosis.
• Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
• Subject has active endocarditis or a history of infective endocarditis.
• 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.
• Subject has a known history of leukopenia (defined as a white blood cell \[WBC\] count \<3.5 x 103/µL).
• Subject has a known history of acute or chronic anemia (defined as hemoglobin \[Hgb\] \<10.0 g/dl or 6 mmol/L).
• Subject has a known history of thrombocytopenia (defined as platelet count \<50 x 103/µL).
• Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs.
• 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.
• Subject needs emergency cardiac or vascular surgery or intervention.
• Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
• Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
• Subject or parent/legal representative refuses blood transfusions.
• Subject has medical, social, or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
• Subject is participating in an investigational study of a new drug, biologic, or device at the time of study screening. \-