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

NCT05462041 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY00002090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organ Transplant

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation.

  Percentage of subjects with incidence of heart graft-related Serious Adverse Events (HGRSAEs) in the DCD Heart Transplanted Recipient Population

  30 days post-heart transplant

Secondary Outcomes (1)

• Assess the practical, financial and logistical viability of using NRP vs. DPP for the procurement of DCD donor hearts.

  1 year

Study Arms (2)

DBD Donor Heart Transplantation

OTHER

If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.

Other: DBD Donor Heart Transplantation

DCD Donor Heart Transplantation

OTHER

If the heart offer is from a DCD donor, the heart will be retrieved using one of two strategies: Normothermic Regional Perfusion (NRP) or Direct Procurement and Perfusion (DPP). NRP procedures will be used to procure all DCD hearts unless contraindicated or prohibited by the donor hospital. In the event the donor hospital does not allow NRP for cardiac organ procurement, or the target number of eight DCD transplants with NRP has been achieved, DPP with the Organ Care System (OCS) should be utilized.

Device: DCD Donor Heart Transplantation

Interventions

DBD Donor Heart Transplantation OTHER

A technique of donor heart procurement.

DBD Donor Heart Transplantation

DCD Donor Heart Transplantation DEVICE

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.

DCD Donor Heart Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male or female, aged 18 years of age or older listed for primary heart transplant

You may not qualify if:

• Prior history of cardiac transplantation
• Multi-organ transplant
• Current or planned participation in another interventional trial
• Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Study Officials

• Fardad Esmailian, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director, Heart Transplantation and Mechanical Circulatory Support

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: May 24, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)