Global Utilization And Registry Database for Improved heArt preservatioN
NCT ID: NCT04141605
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
3000 participants
OBSERVATIONAL
2020-02-14
2029-12-31
Brief Summary
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Detailed Description
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Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution.
This study will be conducted at an estimated 25 institutions globally and will have about up to 3000 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, 1-year, 2-years, 3-years, 4-years, 5-years).
GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning, Inotrope use, CAV diagnosis, rejection, and survival.
Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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SherpaPak CTS Patients
Patients whose donor heart was transported with the SherpaPak CTS
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.
Standard Transport Patients
Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Registered male or female primary heart transplant candidates including pediatric candidates
Exclusion Criteria
* 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
ALL
No
Sponsors
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Paragonix Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Zuckermann, MD
Role: PRINCIPAL_INVESTIGATOR
ALLGEMEINES KRANKENHAUS WIEN
Locations
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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
Countries
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References
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Lerman JB, Patel CB, Casalinova S, Nicoara A, Holley CL, Leacche M, Silvestry S, Zuckermann A, D'Alessandro DA, Milano CA, Schroder JN, DeVore AD. Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System. Circ Heart Fail. 2024 May;17(5):e010904. doi: 10.1161/CIRCHEARTFAILURE.123.010904. Epub 2024 Apr 11.
D'Alessandro D, Schroder J, Meyer DM, Vidic A, Shudo Y, Silvestry S, Leacche M, Sciortino CM, Rodrigo ME, Pham SM, Copeland H, Jacobs JP, Kawabori M, Takeda K, Zuckermann A. Impact of controlled hypothermic preservation on outcomes following heart transplantation. J Heart Lung Transplant. 2024 Jul;43(7):1153-1161. doi: 10.1016/j.healun.2024.03.010. Epub 2024 Mar 19.
Moayedifar R, Shudo Y, Kawabori M, Silvestry S, Schroder J, Meyer DM, Jacobs JP, D'Alessandro D, Zuckermann A. Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry. J Heart Lung Transplant. 2024 Apr;43(4):673-680. doi: 10.1016/j.healun.2023.12.013. Epub 2023 Dec 30.
Shudo Y, Leacche M, Copeland H, Silvestry S, Pham SM, Molina E, Schroder JN, Sciortino CM, Jacobs JP, Kawabori M, Meyer DM, Zuckermann A, D'Alessandro DA. A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes in Recipients of Donor Hearts Preserved With the SherpaPak System. ASAIO J. 2023 Nov 1;69(11):993-1000. doi: 10.1097/MAT.0000000000002036. Epub 2023 Apr 5.
Other Identifiers
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PGX-002
Identifier Type: -
Identifier Source: org_study_id
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