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Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation

NCT05038943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-09-28

No results posted yet for this study

Summary

This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (TA-NRP). SherpaPak™ CTS is an ultraportable hypothermic preservation and transport system that has been approved by United States Food \& Drug Administration (FDA) for clinical use in heart transplantation.

Conditions

  • Heart Transplant Failure
  • Determination of Death
  • Outcomes Research
  • Extracorporeal Membrane Oxygenation

Interventions

DEVICE

Paragonix SherpaPak Cardiac Transport System

Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Marian Urban, MD, PhD · Assistant Professor

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-04-08
Completion
2022-04-08
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05038943 on ClinicalTrials.gov