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

Paragonix Technologies

Status

Invitation-only

Conditions

Heart Defects, Congenital

Heart Failure

Heart Diseases

Treatments

Device: SherpaPak Cardiac Transport System

Study type

Observational

Funder types

Industry

Identifiers

NCT04141605

PGX-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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