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OCS-CAR-121918 Continued Access Protocol to collect additional evidence to evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (Heart EX

NCT03835754

Continued Access Protocol to collect additional evidence to evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (Heart EXPAND CAP)

Associated Conditions

Heart Transplant

Principal Investigator

Sponsor

Transmedic

The purpose of this study is to continue to evaluate the performance of the OCS™ System and collect additional clinical data from patients transplanted with donor hearts preserved using the OCS Heart System while the OCS Heart EXPAND Trial is under review at FDA. 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 and you receive a donor heart preserved on the OCS Heart System, you will receive a donor heart that currently may go unused because of concerns that it may be injured during cold storage.