Global Utilization And Registry Database for Improved heArt preservatioN

Brief Summary

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method. CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.