Status:
COMPLETED
Trial to Compare the SherpaPak™ Device vs Cold Storage
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Organ Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
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% chan...
Eligibility Criteria
Inclusion
- 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
- Re-do heart transplant
- Multi-organ transplant
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05194514
Start Date
May 11 2022
End Date
August 31 2024
Last Update
February 21 2025
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048