Organ TransplantNCT05462041
DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors
A study testing DBD Donor Heart Transplantation and DCD Donor Heart Transplantation in people with Organ Transplant, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplant
- What is being tested?
- DBD Donor Heart Transplantation and DCD Donor Heart Transplantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Recipient Inclusion Criteria:
- 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
Recipient Exclusion Criteria:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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.
Read the detailed description
In the U.S., heart donation occurs after a person has been declared brain dead and is called a donor after brain death (DBD). In these patients, the heart continues to beat and pump blood throughout the body. After life support is withdrawn, organs are retrieved immediately for transplantation. This study will use hearts from donors after circulatory death (DCD) donors. DCD donors are those whose hearts have stopped beating and no longer pump blood. DCD hearts are not used as often for transplantation today in the U.S. because they may be further injured during traditional cold storage. In the US, donor hearts are currently mostly obtained from donors after brain death (DBD), although DCD donors are used for other donated organs, such as: lungs, kidneys, and livers.
This study will evaluate whether patients who receive a DCD heart transplant using either NRP or DPP have similar outcomes as patients who receive DBD hearts 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. Ten (10) DCD donor heart recipients will be enrolled into the study intervention group, and approximately 30 DBD donor heart recipients will be enrolled into the control group.
- Conditions
- Organ Transplant
- Being tested
- DBD Donor Heart Transplantation, DCD Donor Heart Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBD Donor Heart TransplantationOther
A technique of donor heart procurement.
DCD Donor Heart TransplantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DBD Donor Heart Transplantation | Other | If the heart offer is from a DBD donor, the heart will be retrieved per standard of care. Receives: 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. Receives: Device: DCD Donor Heart Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
The secondary objective is to assess the practical, financial and logical viability of using NRP vs. DPP for the procurement of DCD donor hearts in this study.
Measured: Time on waitlist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start24 May 2022
- Primary completion31 Aug 2024
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Organ TransplantStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fardad Esmailian, Cedars-Sinai Medical Center
- Investigators
- Fardad Esmailian, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462041
- Sponsor's protocol ID
- STUDY00002090
- Status last verified
- May 2026
- First submitted
- 14 Jul 2022
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05462041
- Acronym / sponsor ID
- STUDY00002090
- Conditions
- Organ Transplant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the U.S., heart donation occurs after a person has been declared brain dead and is called a donor after brain death (DBD). In these patients, the heart continues to beat and pump blood throughout the body. After life support is withdrawn, organs are retrieved immediately for transplantation. This study will use hearts from donors after circulatory death (DCD) donors. DCD donors are those whose hearts have stopped beating and no longer pump blood. DCD hearts are not used as often for transplantation today in the U.S. because they may be further injured during traditional cold storage. In the US, donor hearts are currently mostly obtained from donors after brain death (DBD), although DCD donors are used for other donated organs, such as: lungs, kidneys, and livers.
This study will evaluate whether patients who receive a DCD heart transplant using either NRP or DPP have similar outcomes as patients who receive DBD hearts 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. Ten (10) DCD donor heart recipients will be enrolled into the study intervention group, and approximately 30 DBD donor heart recipients will be enrolled into the control group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBD Donor Heart Transplantation | Other | Other: DBD Donor Heart TransplantationIf the heart offer is from a DBD donor, the heart will be retrieved per standard of care. |
| DCD Donor Heart Transplantation | Other | Device: DCD Donor Heart TransplantationIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBD Donor Heart TransplantationA technique of donor heart procurement. | Other | DBD Donor Heart Transplantation |
| DCD Donor Heart TransplantationA 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. | Device | DCD Donor Heart Transplantation |
Primary outcome
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.
Time frame: 30 days post-heart transplant
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
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Time frame: 30 days post transplant
Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS
1 secondary outcome
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 frame: Time on waitlist
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fardad Esmailian, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBD Donor Heart Transplantation and DCD Donor Heart Transplantation in people with Organ Transplant, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days post-heart transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.