Trial to Compare the SherpaPak™ Device vs Cold Storage

Study Overview
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Brief Summary
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The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts. There are two methods of organ preservation. The first method is the use of cold storage. With this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts. This is also known as standard of care. The second method is the use of the SherpaPak™ Cardiac Transport System. With this method, the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts. The study will include up to 20 people in total.

Detailed Description
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This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio. 50% chance of receiving a donor heart using the SherpaPak™ method, or 50% chance of receiving a donor heart using the cold storage method. The research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. Participants will be in the study for about 30 days.

Official Title
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Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study

Conditions
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Organ Transplant

Intervention / Treatment
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* Device: SherpaPak™ Device
* Other: Cold Storage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any sex/gender, 18 years of age or older listed for primary heart transplant. Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) Exclusion Criteria: Re-do heart transplant Multi-organ transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SherpaPak™ Cardiac Transport System<br>When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. | Device: SherpaPak™ Device<br>* The SherpaPak™ Cardiac Transport System has been developed to provide a safe, consistent method for cold ischemic storage of donor hearts for transplantation. This device is FDA approved.<br>|
| Other: Cold Storage<br>When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. | Other: Cold Storage<br>* FDA-approved method for organ procurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of moderate to severe primary graft dysfunction (left or right ventricle) | Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle) | 24 hours post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify Hemodynamic parameters | Percentage of Cardiac index, cardiac output, blood pressure, mean arterial pressure, pulmonary artery pressure, left atrial pressure, right atrial pressure, right ventricular pressure, stroke volume and ejection fraction | 24 hours post-transplant | 
| Incidence of acute cellular rejection | Percentage of subjects without acute cellular rejection in the first 30 days after transplant | 30 days post-transplant | 
| Incidence of antibody mediated rejection | Percentage of subjects with no antibody mediated rejection in the first 30 days after transplant. | 30 days post-transplant |