Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)

Global Utilization and Registry Database for Improved Heart Preservation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Diseases; Heart Failure; Heart Defects, Congenital
• Intervention / Treatment: Device: SherpaPak Cardiac Transport System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • University of Graz
  • Vienna, Austria, 1090
    • Allgemeines Krankenhaus Wien
• Spain
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Valladolid, Spain
    • Hospital Clínico Universitario de Valladolid
• United Kingdom
  • Manchester, United Kingdom
    • Manchester University
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health Shands Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • Kansas University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts University Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • New York
    • New York, New York, United States, 10032
      • NewYork-Presbyterian Columbia University Irving Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Pennslyvania State University
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SherpaPak CTS Patients; Patients whose donor heart was transported with the SherpaPak CTS	Device: 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 Names: SherpaPak CTS
Standard Transport Patients; Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	Number of related hospitalizations post transplant	one year
CAV development	Number of patients who developed CAV between 1 and 5 years post transplant will be compared	five years
Retransplant	The number of patients who were retransplanted will be compared	five years

Collaborators and Investigators

• Sponsor: Paragonix Technologies
• Investigators: Principal Investigator: Andreas Zuckermann, MD, Allgemeines Krankenhaus Wien

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: PGX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be released as a summary of the results found at each center and overall. No individual patient data will be released.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No