Trial to Compare the SherpaPak™ Device vs Cold Storage

NCT05194514 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00001753
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Organ Transplant

Outcome Measures

Primary Outcomes (5)

• 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

• 30-day Post-transplant Survival

  30 day post heart transplant (htx)

• Freedom From 30-day Ischemic Reperfusion Injury

  30 day post htx

• Freedom From 30-day Biopsy Proven Rejection

  30 day post htx

• Freedom From 30-day Any-treated Rejection

  30 day post htx

Secondary Outcomes (10)

• Cardiac Index

  24 hours post-transplant

• Cardiac Output

  24 hours post-transplant

• Mean Arterial Pressure

  24 hours post-transplant

• Pulmonary Arterial Pressure

  24 hours post-transplant

• Vasoactive-Inotropic Score

  24 hours post-transplant

Study Arms (2)

SherpaPak™ Cardiac Transport System

OTHER

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

Cold Storage

OTHER

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

Interventions

SherpaPak™ Device DEVICE

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.

SherpaPak™ Cardiac Transport System

Cold Storage OTHER

FDA-approved method for organ procurement

Cold Storage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Re-do heart transplant
• Multi-organ transplant

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Cryopreservation

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Limitations and Caveats

There are several limitations to our study. First, the small sample size limits our ability to detect clinical differences between the groups. Second, our primary clinical end points were only followed out to 30-days warranting further randomized trials aimed at assessing the long-term effects on clinical outcomes. Third, cardiac samples have a high dynamic range of proteins due to the abundance of contractile machinery within cardiomyocytes.

Results Point of Contact

• Title: Fardad Esmailian
• Organization: Cedars-Sinai

fardad.esmailian@cshs.org

310-248-7132

Study Officials

• Fardad Esmailian

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 18, 2022
• Study Start: May 11, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year after the study is closed.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)