Trial ID or NCT#

NCT01757665

Status

NOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

D. Craig Miller, M.D.
Cardiovascular surgeon
Thelma and Henry Doelger Professor in Cardiovascular Surgery

Contact us to find out if this trial is right for you.

CONTACT

Kokil Bakshi, MSBA
(650) 498-1232