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DCD Heart CAP Organ Care System (OC) Heart System: OCS DCD Heart Continued Access Protocol (CAP)

NCT04615182

Organ Care System (OC) Heart System: OCS DCD Heart Continued Access Protocol (CAP)

Principal Investigator

Sponsor

Transmedic

This study is a continuation of the OCS Heart DCD trial. The purpose of this study is to continue to evaluate whether the OCS Heart System may be used to preserve hearts obtained from donors after circulatory death (DCD) and to evaluate whether these DCD hearts may be successfully transplanted while the OCS Heart DCD trial data are provided to and under review at FDA. Currently, DCD hearts are not used for transplantation in the U.S. but they are used in Europe and Australia where the OCS Heart System is commercially available. The OCS Heart System is the only technology which has been shown to allow for successful transplantation of DCD hearts. This study will continue to evaluate patients who receive a DCD heart transplant. The study will also evaluate the ability of the OCS Heart System to make more hearts available for transplantation and will monitor their post-transplant clinical outcomes. If you participate in this study, you will have the possibility of receiving a DCD heart preserved on the OCS Heart System.

This study is currently enrolling.