TransMedics Heart DCD CAP

Summary

This study focuses on individuals who have been listed to receive a heart transplant and whose doctor has determined that they may be a suitable candidate for the study. The study aims to evaluate the investigational use of the TransMedics Organ Care System (OCS). The OCS System may be used to preserve hearts obtained from donors after circulatory death (DCD). Researchers will evaluate patients who receive a DCD heart transplant (from donors whose hearts have stopped beating and no longer pump blood). DCD hearts are not used for transplantation in the U.S., but they are used in other countries where the OCS Heart System is commercially available. (In the U.S., donor hearts are currently only obtained from donors after brain death). Researchers will also evaluate the ability of the OCS Heart System to make more hearts available for transplantation and will monitor post-transplant clinical outcomes.


Inclusion Criteria

  • • Primary heart transplant candidates
  • Age ≥ 18 years old
  • Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

The Portable Organ Care System Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol

Details
Disease Type/Condition

Heart

Principal Investigator

Esmailian, Fardad

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001132

ClinicalTrials.gov ID

NCT04615182

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

Principal Investigator

Esmailian, Fardad

Age Group

Adult

Phase

N/A

IRB Number

OCS-CAR-08242020

ClinicalTrials.gov ID

NCT04615182

Key Eligibility
ClinicalTrials.gov

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