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TransMedics DCD Heart - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if a new device can preserve hearts after they stop beating and if these hearts can be successfully transplanted.
What is the Condition Being Studied?
Heart transplantation

Who Can Participate in the Study?

Adults who are heart transplant candidates.

Age Group
Adults

What is Involved?

If you agree to be in this study you will:

-Be randomized (like the flip of a coin) to receive:
----Group 1: A heart stored on ice, or
----Group 2: A heart that is being maintained on a device (unless a heart stored on ice becomes available first)

Study Details

Full Title
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS¿) Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death (DCD Heart Trial)
Principal Investigator
Protocol Number
IRB: PRO00102769
NCT: NCT03831048
Phase
Phase N/A
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698