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Life sciences · Observational Study
ClinicalTrials.gov · October 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04141605). This is a study registration, not published results. Lead sponsor: Paragonix Technologies. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 4000 participants (ESTIMATED). Conditions: Heart Diseases, Heart Failure, Heart Defects, Congenital. Interventions: DEVICE: SherpaPak Cardiac Transport System. Primary outcome measures: Number of Patients with Primary Graft Dysfunction , one year; Number of Patients with Right Ventricular Dysfunction , one year; Length of ICU Stay , one year; Length of Hospital Stay , one year; Survival , 5 years. Brief 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. CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.