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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04141605
Other study ID # PGX-002
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 14, 2020
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Paragonix Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Austria University of Graz Graz
Austria Allgemeines Krankenhaus Wien Vienna
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Clínico Universitario de Valladolid Valladolid
United Kingdom Manchester University Manchester
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts University Medical Center Boston Massachusetts
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Baylor University Medical Center Dallas Texas
United States Duke University Durham North Carolina
United States Lutheran Hospital Fort Wayne Indiana
United States University of Florida Health Shands Hospital Gainesville Florida
United States Spectrum Health Grand Rapids Michigan
United States Mayo Clinic Jacksonville Florida
United States Kansas University Medical Center Lawrence Kansas
United States Le Bonheur Children's Hospital Memphis Tennessee
United States NewYork-Presbyterian Columbia University Irving Medical Center New York New York
United States Sentara Healthcare Norfolk Virginia
United States AdventHealth Orlando Orlando Florida
United States Stanford University Stanford California
United States Pennslyvania State University State College Pennsylvania
United States Medstar Washington Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Paragonix Technologies

Countries where clinical trial is conducted

United States,  Austria,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Length of ICU Stay Length of time patient admitted to the intensive care unit post transplant one year
Primary Length of Hospital Stay Length of time before patient is discharged from the hospital post transplant one year
Primary Survival The length of patient survival up to 5 years will be compared 5 years
Secondary Hospitalizations Number of related hospitalizations post transplant one year
Secondary CAV development Number of patients who developed CAV between 1 and 5 years post transplant will be compared five years
Secondary Retransplant The number of patients who were retransplanted will be compared five years
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