ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

Exclusion Criteria

• •A subject meeting any of the following criteria shall be excluded:
• •1. Requires emergency surgery
• •2. Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
• •3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
• •4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
• •5. Requires surgical replacement of the aortic root
• •6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
• •7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit
• •8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery
• •9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
• •10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
• •11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
• •12. Diagnosed with abnormal calcium metabolism and hyperparathyroidism
• •13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
• •14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
• •15. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
• •16. Documented leukopenia (WBC \< 3.5x 10³/μL), acute anemia (Hgb \< 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count \< 50x 10³/μL) accompanied by history of bleeding diathesis and coagulopathy
• •17. Has prior organ transplant or is currently an organ transplant candidate
• •18. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
• •19. Was previously implanted with trial device (Model 11000A or Model 11000M)
• •20. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
• •21. Currently incarcerated or unable to give voluntary informed consent
• •22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
• •23. Requires concomitant left ventricular assist device (LVAD) placement