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

Study Overview
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Brief Summary
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The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

Detailed Description
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Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.

Official Title
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ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

Conditions
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Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure, Aortic Stenosis

Intervention / Treatment
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* Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria: Inclusion Criteria: 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 Exclusion criteria: A subject meeting any of the following criteria shall be excluded: Requires emergency surgery Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve repair) Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass) 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 renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mg/dL or end -stage renal disease requiring chronic dialysis at screening visit 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 Has presence of non-cardiac disease limiting life expectancy to less than 12 months Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) Diagnosed with abnormal calcium metabolism and hyperparathyroidism Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days 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 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) 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 Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant Requires concomitant left ventricular assist device (LVAD) placement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M<br>Aortic/Mitral valve replacement therapy | Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M<br>* Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Structural Valve Deterioration | The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear. | 1 Year Post Implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Early Adverse Events | Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100 | Events occuring within 30 days of procedure | 
| Percentage of Late Adverse Events Divided by Late Patient Years | Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 3 years post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve replacement, Mitral valve replacement