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

Prior treatment

• Requires emergency surgery
• Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
• Requires surgical replacement of the aortic root
• Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
• 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
• Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
• Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
• Has prior organ transplant or is currently an organ transplant candidate
• Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
• Was previously implanted with trial device (Model 11000A or Model 11000M)
• Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
• Requires concomitant left ventricular assist device (LVAD) placement

Other illness

• Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
• Has presence of non-cardiac disease limiting life expectancy to less than 12 months
• Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation

Lab values

• 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
• Diagnosed with abnormal calcium metabolism and hyperparathyroidism
• Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
• 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

Other

• A subject meeting any of the following criteria shall be excluded:
• Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair)
• Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
• Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
• Currently incarcerated or unable to give voluntary informed consent

• Is 18 years or older
• Provides written informed consent prior to trial procedures
• Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB or the same healthcare system
• Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
• Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
• Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement

Criteria the registry did not label

• Eligibility Criteria: