Global Utilization And Registry Database for Improved heArt preservatioN

NCT04141605 | Enrolling By Invitation FDA Device

• 1 other identifier: PGX-002
• Study Type: observational
• Target: 3,000
• Locations: 4 countries
• Sites: 22

Brief 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.

Conditions

Heart Diseases; Heart Failure; Heart Defects, Congenital

Outcome Measures

Primary Outcomes (5)

• Number of Patients with Primary Graft Dysfunction

  Less than 40% LVEF by echocardiography or hemodynamics with RAP greater than 15 mm Hg, PCWP greater than 20 mm Hg, CI less thann 2 L/min/m\^2, hypotension with MAP less than 70 mm Hg (lasting more than 1 hour)

  one year

• Number of Patients with Right Ventricular Dysfunction

  hemodynamics with RAP grater than 15mm Hg, PCWP less than 15 mm Hg, CI less than 2 L/min/m\^2, TPG less than 15mm Hg/pulmonary artery systolic pressure less than 50 mmHg OR need for RVAD

  one year

• Length of ICU Stay

  Length of time patient admitted to the intensive care unit post transplant

  one year

• Length of Hospital Stay

  Length of time before patient is discharged from the hospital post transplant

  one year

• Survival

  The length of patient survival up to 5 years will be compared

  5 years

Secondary Outcomes (3)

• Hospitalizations

  one year

• CAV development

  five years

• Retransplant

  five years

Study Arms (2)

SherpaPak CTS Patients

Patients whose donor heart was transported with the SherpaPak CTS

Device: SherpaPak Cardiac Transport System

Standard Transport Patients

Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years

Interventions

SherpaPak Cardiac Transport System DEVICE

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.

Also known as: SherpaPak CTS

SherpaPak CTS Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered on the heart transplant registry who receive a heart transplant at a participating center and do not meet any of the exclusion criteria.

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

Sponsors & Collaborators

• Paragonix Technologies: lead

Study Sites (22)

Stanford University

Stanford, California, 94305, United States

Location

Medstar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Lutheran Hospital

Fort Wayne, Indiana, 46804, United States

Location

Kansas University Medical Center

Lawrence, Kansas, 66045, United States

Location

Tufts University Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

NewYork-Presbyterian Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Pennslyvania State University

State College, Pennsylvania, 16801, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Sentara Healthcare

Norfolk, Virginia, 23507, United States

Location

University of Graz

Graz, 8036, Austria

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Manchester University

Manchester, United Kingdom

Location

Related Publications (4)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andreas Zuckermann, MD

  ALLGEMEINES KRANKENHAUS WIEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 28, 2019
• Study Start: February 14, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); AU (2); US (17); GB (1)