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

NCT05462041 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: STUDY00002090
• Study Type: interventional
• Target: 40
• 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 (2)

• The Primary Objective of This Proposed Research is to Evaluate the Safety of Utilizing DCD Donor Hearts as Compared to DBD Donor Hearts for Transplantation.

  The primary objective of this proposed research is to evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation HGRSAE (Heart Graft Related Serious Adverse Event) in the first 30 days post-transplan

  30 days post-heart transplant

• Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant

  Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS

  30 days post transplant

Secondary Outcomes (1)

• The Secondary Objective is to Assess the Practical, Financial and Logical Viability of Using NRP vs. DPP for the Procurement of DCD Donor Hearts

  Time on waitlist

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

Results Point of Contact

• Title: Shruti Shantharam
• Organization: Cedars-Sinai

shruti.shantharam@csmns.org

3102488365

Study Officials

• Fardad Esmailian, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 30, 2026
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-05

Locations

US (1)