GUARDIAN-Liver Registry

Study Synopsis

GUARDIAN will include transplant centers across the U.S. and Europe. The primary objectives of the post-market registry study are to evaluate short term post-transplant outcomes (within the first 48 hours), intermediate term outcomes (within the first 30 days) and long-term outcomes (1-year survival).

There will be no changes to existing standard protocols involved in donor heart transplantation. The registry study will also further analyze the impact of a variety of donor, recipient and transport-related parameters on patient outcomes, including donor clinical backgrounds, total ischemic times and recipient factors.

Study Product

The Paragonix SherpaPak™ Cardiac Transport System has received FDA clearance and is a CE-marked medical device intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Paragonix SherpaPak™ Cardiac Transport System is up to 4 hours.

Regulatory Status

GUARDIAN is a post-market clinical evaluation study. The study became WIRB approved August 2019. The Paragonix SherpaPak Cardiac Transport System utilized in this registry is cleared for marketing by the FDA and is CE Marked for the intended use under study

Study Objective

The objective of GUARDIAN is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor hearts that were preserved and transported within the Paragonix SherpaPak™ Cardiac Transport System.

Study Design

The GUARDIAN study is a post-market, observational registry of adult and pediatric heart transplant recipient patients whose donor heart was preserved and transported using the Paragonix SherpaPak™ Cardiac Transport System or standard of care methods. The data are being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

Study Center

About 25 clinical sites will be included within this registry.

Treatment Plan

Primary heart transplant candidates will be screened for study eligibility. Every eligible candidate will be asked to participate. Donor hearts will be evaluated for suitability for transplantation and study eligibility. Eligible heart transplant candidates will be enrolled consecutively as they present at each site and will receive donor hearts preserved using the Paragonix SherpaPak™ Cardiac Transport System.

Inclusion Criteria

DONOR: Donor and donor hearts matched to the prospective recipient based upon institutional medical practice.

RECIPIENT: Registered male or female primary heart transplant candidates including pediatric candidates.

Exclusion Criteria

RECIPIENT: Donor and donor lungs that do not meet institutional clinical requirements for transplantation. As well as patients who are incarcerated persons (prisoners), patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas), and patients who are receiving multiple organ transplants.

DONOR: Patients who are incarcerated persons (prisoners), patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas), and patients who are receiving multiple organ transplants.

Follow-Up Period

All subjects will be followed through 1-year following recipient transplant (e.g., 24 hours, discharge, 30-days, 1-year).

Study Duration

On-going data collection through five years.

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Primary Outcome Measures

Collection and analysis of clinical and laboratory data from donor and transplant recipient subjects of which donor hearts were transported using the Paragonix SherpaPak™ Cardiac Transport System.

Safety Measures

All relevant adverse events will be reported.

Lead Investigators

Dr. David D’Alessandro
Massachusetts General Hospital (Boston, USA)

Dr. Andreas Zuckermann
AKH Wien Hospital (Vienna, Austria)

Dr. Jonathan Philpott
Sentara Healthcare (Norfolk, USA)

Dr. Marzia Leacche
Spectrum Health Systems (Grand Rapids, USA)

Dr. Si Pham
Mayo Clinic Florida (Jacksonville, USA)

Dr. Juan Bustamante-Munguira
Hospital Clinico Universitario de Valladolid (Valladolid, Spain)

Dr. Ezequiel Molina
MedStar Washington Hospital Center (Washington, D.C.)

Dr. Yasuhiro Shudo
Stanford Medical Center (Stanford, USA)

Dr. Jeffrey Jacobs
University of Florida Health Shands (Gainesville, USA)

Dr. Scott Silvestry
AdventHealth (Orlando, USA)

Dr. Jacob Schroder
Duke University Hospital (Durham, USA)

Dr. Jonathan Philpott
Sentara Norfolk General (Norfolk, USA)

Dr. Dan Meyer
Baylor University Medical Center (Dallas, USA)

Dr. Hannah Copeland
Lutheran Health (Fort Wayne, USA)

Dr. Andrea Eixerés Esteve
Hospital Universitario 12 de Octubre (Madrid, Spain)

Dr. Masashi Kowabori
Tufts Medical Center (Boston, USA)

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