Condition: Heart transplant
Randomized Trial to Compare the SherpaPak Device Versus Cold Storage of Donor Hearts in Transplantation: A Pilot Study (IRB no. 00001753)
This study focuses on individuals who are in need of a heart transplant. The purpose of the study is to determine which of 2 methods of organ preservation leads to better outcomes for donated hearts. The first method is the use of cold storage, in which the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts and is considered standard-of-care. The second method is the use of the SherpaPak Cardiac Transport System, in which the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts. The participant’s donor heart will either be placed in cold storage or the SherpaPak Cardiac Transport System (based on a random assignment to either group).
The U.S. Food and Drug Administration (FDA) has approved the SherpaPak Cardiac Transport System as it is being used in this study.