Global Utilization And Registry Database for Improved heArt preservatioN

Enrolling by invitation

Conditions studied: Heart Diseases, Heart Failure, Heart Defects, Congenital

In brief

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.

Key facts

Study ID

NCT04141605

Run by

Paragonix Technologies

People needed

3000

Starts

2020-02-14

Expected to finish

2029-12-31

Last updated by the study team

2025-05-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Donor and donor hearts that do not meet institutional clinical requirements for transplantation
• 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)
• Patients who have had a previous organ transplant

Where it is running

• Stanford University — Stanford, California, United States
• Medstar Washington Hospital — Washington D.C., District of Columbia, United States
• University of Florida Health Shands Hospital — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Lutheran Hospital — Fort Wayne, Indiana, United States
• Kansas University Medical Center — Lawrence, Kansas, United States
• Tufts University Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• NewYork-Presbyterian Columbia University Irving Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Pennslyvania State University — State College, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Sentara Healthcare — Norfolk, Virginia, United States
• University of Graz — Graz, Austria
• Allgemeines Krankenhaus Wien — Vienna, Austria
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Clínico Universitario de Valladolid — Valladolid, Spain
• Manchester University — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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