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

Inclusion Criteria:

1. Male or female, age 18 years or older
2. Provides written informed consent prior to trial procedures
3. Diagnosed with aortic valve disease requiring a planned replacement as indicated in the preoperative evaluation
4. Scheduled to undergo planned aortic valve replacement with or without concomitant bypass surgery
5. Geographically stable and agrees to attend all follow-up assessments at the hospital of sur-gical services for up to 5 years

Exclusion Criteria:

1. Requires emergency surgery
2. Has prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
3. Requires multiple valve replacement/repair
4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
5. Has aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic valve replacement (AVR) 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 AVR surgery
9. Has acute myocardial infarction (MI) within 30 days prior to AVR 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 hyperparathyroidism
13. Exhibits left ventricular ejection fraction ≤ 30% as validated by diagnostic procedure within 30 days prior to AVR 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 60 days prior to AVR surgery
16. Documented leukopenia (WBC < 3.5x 103/µL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count < 50x103/µL) or history of bleeding diathesis or coagulopathy
17. Diagnosed with myxomatous disease/connective tissue disorders (e.g. Marfan's Syndrome)
18. Has prior organ transplant
19. Current or recent participation (within 6 weeks prior to surgery) in another investigational drug or device trial
20. Was previously implanted with trial device
21. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
22. Currently incarcerated or unable to give voluntary informed consent
23. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant -