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

Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.

This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years.

Inclusion Criteria:

1. Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
2. Is greater than or equal to 5 years of age
3. Subject and/or subject's legal representative has provided written informed consent as approved and required by the respective institutional review board and agrees to its provisions. NOTE: Written consent must be obtained prior to any research related test being performed.

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