Tracks heart transplant outcomes when donor hearts are moved in a special transport device
Studies heart transplant results when donor hearts travel in the SherpaPak device.
Plain-language title generated from the registry record
Registry title: Global Utilization And Registry Database for Improved heArt preservatioN
Key facts
- Where
- Boston, Cincinnati, Dallas, Durham, Fort Wayne, Gainesville, Grand Rapids, Jacksonville, Lawrence, Memphis, New York, Norfolk, Orlando, Stanford, State College, and Washington D.C., United StatesSee the 17 sites
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Tufts University Medical CenterBoston, United StatesNo longer taking part
- Cincinnati Children's HospitalCincinnati, United StatesNo longer taking part
- Baylor University Medical CenterDallas, United StatesNo longer taking part
- Duke UniversityDurham, United StatesNo longer taking part
- Lutheran HospitalFort Wayne, United StatesNo longer taking part
- University of Florida Health Shands HospitalGainesville, United StatesNo longer taking part
- Spectrum HealthGrand Rapids, United StatesNo longer taking part
- Mayo ClinicJacksonville, United StatesNo longer taking part
- Kansas University Medical CenterLawrence, United StatesNo longer taking part
- Le Bonheur Children's HospitalMemphis, United StatesNo longer taking part
- NewYork-Presbyterian / Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- Sentara HealthcareNorfolk, United StatesNo longer taking part
- AdventHealth OrlandoOrlando, United StatesNo longer taking part
- Stanford UniversityStanford, United StatesNo longer taking part
- Pennslyvania State UniversityState College, United StatesNo longer taking part
- MedStar Washington HospitalWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Paragonix Technologies
- Trial code
- NCT04141605
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
Global Utilization and Registry Database for Improved Heart Preservation
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.
Inclusion: Donor and donor hearts matched to the prospective recipient based upon institutional medical practice; Registered male or female primary heart transplant candidates including pediatric candidates.
Exclusion: Donor and donor hearts that do not meet institutional clinical requirements for transplantation; Patients who have had a previous organ transplant; When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root; Patients who are incarcerated persons (prisoners).