SherpaPak IIT

Summary

This study focuses on individuals who are in need of a heart transplant. The purpose of the study is to determine which of 2 methods of organ preservation leads to better outcomes for donated hearts. The first method is the use of cold storage, in which 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 and is considered standard-of-care. The second method is the use of the SherpaPak Cardiac Transport System, in which the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts. The participant's donor heart will either be placed in cold storage or the SherpaPak Cardiac Transport System (based on a random assignment to either group). The U.S. Food and Drug Administration (FDA) has approved the SherpaPak Cardiac Transport System as it is being used in this study.


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)
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Heart failure

Principal Investigator

Esmailian, Fardad

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001753

ClinicalTrials.gov ID

NCT05194514

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Heart failure

Principal Investigator

Esmailian, Fardad

Age Group

Adult

Phase

N/A

IRB Number

SHERPAPAK-IIT

ClinicalTrials.gov ID

NCT05194514

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?