CAMBRIDGE, MASSACHUSETTS, June 2, 2020- Paragonix Technologies, Inc. today announced that its clinical global registry, the Global Utilization And Registry Database for Improved Heart Preservation (GUARDIAN), has reached enrollment of over 100 patients that have received a donor heart.
Patients that have received donor hearts using either the Paragonix’s SherpaPak™ Cardiac Transport System (CTS) or the ice cooler method have been enrolled. GUARDIAN, a registered clinical trial, is open to all heart transplant centers who are looking to analyze patient outcomes based on donor heart preservation methods. The study is the first of its kind. As Dr. Jonathan Philpott from Sentara Norfolk General Hospital stated, “The ability to enroll both patients with hearts preserved using Paragonix SherpaPak CTS and with the conventional ice cooler method will be an invaluable additional analysis.”
Moreover, in response to the ongoing COVID-19 pandemic, GUARDIAN has been expanded to also capture COVID-19 related testing data. Heart transplant outcome analyses can now include this important infectious disease parameter to understand its effect on clinical outcomes in this patient population. “Paragonix is proud to support the clinical community with this powerful data collection platform—and to continue contributing to the rigorous analyses of clinical data surrounding heart preservation and transplant outcomes, especially given the new realities posed by the COVID-19 pandemic,” says Paragonix Chairman and CEO, Bill Edelman.
Currently, four sites have enrolled patients into the GUARDIAN registry: Massachusetts General Hospital (Boston, MA), Spectrum Health (Grand Rapids, MI), Sentara (Norfolk, VA) and Allgemeines Krankenhaus Wien (Vienna, Austria).
With a focus on 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), the registry seeks to advance the method and technologies used as part of the organ preservation and transplantation journey. Massachusetts General Hospital’s Surgical Director of Heart Transplantation, Dr. David D’Alessandro, states that “GUARDIAN is a significant step forward in evaluating this technology and its impact on organ transplantation. This registry is critically important to determine the therapeutic effect to this type of organ preservation.”
“This international clinical registry will provide important insights into the management of donor hearts in normal times as well as during the global COVID-19 pandemic,” says Prof. Dr. Andreas Zuckermann from Allgemeines Krankenhaus Wien.