GUARDIAN 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. 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: 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.

DONOR: Donor and donor hearts that do not meet institutional clinical requirements for transplantation.

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.

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. Andreas Zuckermann
AKH Wien Hospital (Vienna, Austria)

Dr. Masaki Funamoto
Massachusetts General Hospital (Boston, USA)

Dr. Jonathan Philpott
Sentara Healthcare (Norfolk, USA)

Dr. Theodore Boeve
Spectrum Health Systems (Grand Rapids, USA)

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