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

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ClinicalTrials.gov Identifier: NCT04141605
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2019
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Paragonix Technologies

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.

Condition or disease Intervention/treatment
Heart Diseases Heart Failure Heart Defects, Congenital 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 500 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, and 1-year).

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 and Inotrope use.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Global Utilization and Registry Database for Improved Heart Preservation
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

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 Name: SherpaPak CTS

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



Primary Outcome Measures :
  1. Number of Patients with Primary Graft Dysfunction [ Time Frame: one year ]
    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)

  2. Number of Patients with Right Ventricular Dysfunction [ Time Frame: one year ]
    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

  3. Length of ICU Stay [ Time Frame: one year ]
    Length of time patient admitted to the intensive care unit post transplant

  4. Length of Hospital Stay [ Time Frame: one year ]
    Length of time before patient is discharged from the hospital post transplant


Secondary Outcome Measures :
  1. Hospitalizations [ Time Frame: one year ]
    Number of related hospitalizations post transplant

  2. Quality of Recovery [ Time Frame: one year ]
    Karnofsky score of patients as they recover will be compared. 100 is the highest score and 0 is the lowest. Higher scores are better outcomes and lower scores are worse outcomes.

  3. Speed of Recovery [ Time Frame: one year ]
    How quickly patients achieve a higher Karnofsky score during recovery will be compared. 100 is the highest score and 0 is the lowest. Higher scores are better outcomes and lower scores are worse outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141605


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Virginia
Sentara Healthcare
Norfolk, Virginia, United States, 23507
Austria
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Sponsors and Collaborators
Paragonix Technologies
Investigators
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Principal Investigator: Andreas Zuckermann, MD ALLGEMEINES KRANKENHAUS WIEN
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Responsible Party: Paragonix Technologies
ClinicalTrials.gov Identifier: NCT04141605    
Other Study ID Numbers: PGX-002
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities