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Global Utilization And Registry Database for Improved heArt preservatioN
Sponsor: Paragonix Technologies
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.
Official title: Global Utilization and Registry Database for Improved Heart Preservation
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2020-02-14
Completion Date
2029-12-31
Last Updated
2025-05-31
Healthy Volunteers
No
Interventions
SherpaPak Cardiac Transport System
The Paragonix SherpaPak Cardiac Transport System ("SherpaPak CTS") is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union. The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached.
Locations (22)
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