Quality and Safety in Health Care, Part XXXIII: Transcatheter Mitral Valve Therapy

The transcatheter mitral valve procedure with the MitraClip device has been clinically available in much of Europe since 2008. In 2013, the Food and Drug Administration permitted MitraClip procedures to be done commercially for those patients with primary severe mitral regurgitation who were not surgical candidates. The COAPT trial is designed to see if the MitraClip procedure should be approved in the United States for those with secondary mitral regurgitation, although it has been used for that purpose in much of Europe for years.

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