ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Edwards Lifesciences
- Enrollment
- 777
- Locations
- 32
- Primary Endpoint
- Subjects With Structural Valve Deterioration
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Subjects With Structural Valve Deterioration
Time Frame: 1 Year Post Implant
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.
Secondary Outcomes
- Percentage of Subjects With Early Adverse Events(Events occuring within 30 days of procedure)
- Percentage of Late Adverse Events Divided by Late Patient Years(Events occurring >= 31 days and up through 3 years post-implant)