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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-04-08

Brief Summary

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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.

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Detailed Description

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The investigators will accept donors between the ages of 18 and 49 without any known history of coronary artery disease, insulin dependent diabetes, or long-term smoking (\>20 pack/years) and normal baseline cardiac function (EF\>50) assessed with transthoracic echocardiogram. Donors will be selected and matched to the recipients based on standard criteria (blood group, cross-match, size match, and clinical stability). The current procedure of donation after circulatory death (DCD) and procurement follows a well-established course. After consent is obtained, the organs are allocated through United Network for Organ Sharing (UNOS). All organs will be recovered with protocolized UNMC DCD TA-NRP technique that involves reestablishment of blood flow in-situ after donor's circulatory arrest using portable venoarterial extracorporeal membrane oxygenation (VA-ECMO). Organs will be transported from a donor site to recipient center with the SherpaPak™ CTS. All organs will be transplanted at Nebraska Medicine. Recipients ("subjects") will be followed from transplant through one-year post-transplantation.

Conditions

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Heart Transplant Failure Determination of Death Outcomes Research Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion will be transported with Paragonix SherpaPak Cardiac Transport System to the recipient center

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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SherpaPak

cardiac allografts recovered from donors after circulatory determined death using thoracoabdominal normothermic regional perfusion will be transported to the recipient center in Paragonix SherpaPak Cardiac Transport System

Group Type EXPERIMENTAL

Paragonix SherpaPak Cardiac Transport System

Intervention Type DEVICE

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

Interventions

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Paragonix SherpaPak Cardiac Transport System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Recipient is ≥ 19 years old
2. Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
3. Recipient meets standard listing criteria for heart transplantation

Exclusion Criteria

1. Recipient is \< 19 years old
2. Recipient, or their designated healthcare proxy, is unable to sign informed consent
3. Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No