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Global Utilization And Registry Database for Improved heArt preservatioN

NCT04141605 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

SherpaPak Cardiac Transport System

The Paragonix SherpaPak Cardiac Transport System ("SherpaPak CTS") is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union. The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached.

Sponsors & Collaborators

  • Paragonix Technologies

    lead INDUSTRY

Principal Investigators

  • Andreas Zuckermann, MD · ALLGEMEINES KRANKENHAUS WIEN

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141605 on ClinicalTrials.gov