Global Utilization And Registry Database for Improved heArt preservatioN

Официальное название

Global Utilization and Registry Database for Improved Heart Preservation

Обзор

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.

Подробное описание

This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study.

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.

Вмешательства

• Устройство 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 shel

Первичные конечные точки

• Number of Patients with Primary Graft Dysfunction [Срок оценки: one year]
• Number of Patients with Right Ventricular Dysfunction [Срок оценки: one year]
• Length of ICU Stay [Срок оценки: one year]
• Length of Hospital Stay [Срок оценки: one year]
• Survival [Срок оценки: 5 years]

Вторичные конечные точки (3)

• Hospitalizations [Срок оценки: one year]
• CAV development [Срок оценки: five years]
• Retransplant [Срок оценки: five years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 17 центров

• Stanford University — Stanford
• Medstar Washington Hospital — Washington D.C.
• University of Florida Health Shands Hospital — Gainesville
• Mayo Clinic — Jacksonville
• AdventHealth Orlando — Orlando
• Lutheran Hospital — Fort Wayne
• Kansas University Medical Center — Lawrence
• Tufts University Medical Center — Boston
• … и ещё 9 центров

Австрия · 2 центра

• University of Graz — Graz
• Allgemeines Krankenhaus Wien — Vienna

Испания · 2 центра

• Hospital Universitario 12 de Octubre — Madrid
• Hospital Clínico Universitario de Valladolid — Valladolid

Великобритания · 1 центр

• Manchester University — Manchester

Публикации

• DeFilippis EM, Rodrigo ME, Loyaga-Rendon R, Shudo Y, Uriel N, Takeda K, D'Alessandro DA, Fiedler A. Preservation Strategy and Sex-Specific Risk of Severe Primary Graft Dysfunction After Heart Transplantation: A GUARDIAN-Heart Analysis. ASAIO J. 2026 May 13. doi: 10.1097/MAT.0000000000002736. Online ahead of print. PMID 42127213
• 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. PMID 38602105
• 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. PMID 38503386
• 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. PMID 38163452
• 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. PMID 37678260

Идентификаторы

NCT: NCT04141605 · PGX-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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