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
- Madrid and Valladolid, SpainSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people on the waiting list for a first heart transplant, including children. The donor heart is carried in the SherpaPak Cardiac Transport System.
- Sex
- All sexes can join.
- Disease stage
- People registered as candidates for a first (primary) heart transplant.
- Earlier treatment
- People who have already had an organ transplant cannot join.
Main reasons for not taking part
- Donor heart does not meet the hospital's requirements for transplant
- Safe connection to the aorta cannot be made, for example the aortic root is not long enough
- People in prison
- People who have had a previous organ transplant
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Hospital Clínico Universitario de ValladolidValladolid, SpainNo 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).