ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
United States777 participantsStarted 2012-12-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
✕. 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