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

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

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 mitral valve.

Specialty Area(s)

Trial Location

Columbia University Medical Center
New York, NY 10032
United States