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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)

Description

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 three hundred twenty-five (325) 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.

Phase

N/A

Inclusion and Exclusion 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

Sites

  • California

    • University of Southern California, Los Angeles, California, 90033

  • Oklahoma

    • Oklahoma Heart Hospital, Oklahoma City, Oklahoma, 73135

  • Kansas

    • University of Kansas Medical Center, Kansas City, Kansas, 66160

  • Texas

    • Baylor College of Medicine, Houston, Texas, 77030

  • Indiana

    • St. Vincent Medical Group, Indianapolis, Indiana, 46290

  • Michigan

    • Spectrum Health Hospital, Grand Rapids, Michigan, 49503

  • Georgia

    • Emory University Hospital Midtown, Atlanta, Georgia, 30308
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