Clinical Trial

Global Utilization And Registry Database for Improved heArt preservatioN

Study acronym: GUARDIAN
Enrolling by Invitation
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-10-24; most recent amendment 2025-05-27.
Trial Details
NCT Number NCT04141605
Lead Sponsor Paragonix Technologies
Conditions Heart Diseases, Heart Failure, Heart Defects, Congenital
Enrollment 3,000 participants
Start Date 2020-02-14
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-31