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ACTIVE NOT RECRUITING
NCT05462041
NA

DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.

Official title: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors Compared to Donor Hearts From Donation After Brain Death (DBD) Donors: A Single Center Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-05-24

Completion Date

2025-12-31

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

OTHER

DBD Donor Heart Transplantation

A technique of donor heart procurement.

DEVICE

DCD Donor Heart Transplantation

A technique of donor heart procurement. The TransMedics' OCS Heart technology is the only portable system available for ex-vivo maintenance of the donor heart in a metabolically active and beating state. It is currently FDA approved for procurement and transport.

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States