COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

Exclusion Criteria

• •A subject meeting any of the following criteria shall be excluded:
• •1. Valve-in-conduit procedure
• •2. Requires emergency surgery
• •3. Has acute myocardial infarction (MI) within 30 days prior to screening date
• •4. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date
• •5. Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
• •6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date
• •7. Has renal insufficiency as determined by creatinine (S-Cr) level \~ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
• •8. Has documented leukopenia (WBC \< 3.5x 103/I-lL), acute anemia (Hgb \<10.0 g/dL or 6 mmol/L), or thrombocytopenia (platelet count \< 50xl03/I-lL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior to screening date
• •9. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
• •10. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
• •11. RVOT aneurysm unless treated during pulmonary valve replacement surgery
• •12. Has prior organ transplant or is currently an organ transplant candidate
• •13. Was previously implanted with INSPIRIS RESILIA Pulmonary valve
• •14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
• •15. Need for concomitant replacement of the aortic, mitral or tricuspid valves
• •16. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
• •17. Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial
• •18. Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers, or planning to become pregnant within 1 year of study valve implant
• •19. Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
• •20. Currently incarcerated or unable to give voluntary informed consent
• •21. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
• •22. Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron
• •23. Patients with hypersensitivity to latex
• •Intra-Op Exclusion Criterion:
• •24. Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation