Global Utilization And Registry Database for Improved heArt preservatioN

Heart Failure Clinical Trial

— GUARDIAN  

Official title:

Global Utilization and Registry Database for Improved Heart Preservation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04141605
• Other study ID #: PGX-002
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure

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