Trial Outcomes & Findings for DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors (NCT NCT05462041)
NCT ID: NCT05462041
Last Updated: 2026-06-30
Results Overview
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
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
30 days post-heart transplant
Results posted on
2026-06-30
Participant Flow
Donors are not considered enrolled. Only recipients.
Participant milestones
| Measure |
Donation After Brain Death- Donor Heart Transplantation
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
Donation After Circulatory Death- Donor Heart Transplantation
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
10
|
|
Overall Study
COMPLETED
|
30
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only females were analyzed as this is a pregnancy metric
Baseline characteristics by cohort
| Measure |
DBD Donor Heart Transplantation
n=30 Participants
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
DCD Donor Heart Transplantation
n=10 Participants
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.
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Recipient age at transplant
|
58.5 Years
n=30 Participants
|
59.0 Years
n=10 Participants
|
59 Years
n=40 Participants
|
|
Age, Continuous
Age of donor heart received.
|
36 Years
n=30 Participants
|
34 Years
n=10 Participants
|
36 Years
n=40 Participants
|
|
Sex/Gender, Customized
Recipient gender · female
|
12 Participants
n=30 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Recipient gender · male
|
18 Participants
n=30 Participants
|
9 Participants
n=10 Participants
|
27 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=30 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=30 Participants
|
4 Participants
n=10 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=30 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=40 Participants
|
|
Recipient Blood Type
A
|
12 Participants
n=30 Participants
|
6 Participants
n=10 Participants
|
18 Participants
n=40 Participants
|
|
Recipient Blood Type
AB
|
2 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=40 Participants
|
|
Recipient Blood Type
B
|
5 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=40 Participants
|
|
Recipient Blood Type
O
|
11 Participants
n=30 Participants
|
4 Participants
n=10 Participants
|
15 Participants
n=40 Participants
|
|
Hypertension
|
22 Participants
n=30 Participants
|
4 Participants
n=10 Participants
|
26 Participants
n=40 Participants
|
|
Diabetes Mellitus
|
9 Participants
n=30 Participants
|
9 Participants
n=10 Participants
|
18 Participants
n=40 Participants
|
|
Chronic Kidney Disease
|
8 Participants
n=30 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=40 Participants
|
|
Ischemic vs. Non-ischemic Cardiomyopathy
Ischemic cardiomyopathy
|
12 Participants
n=30 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=40 Participants
|
|
Ischemic vs. Non-ischemic Cardiomyopathy
Non-ischemic cardiomyopathy
|
18 Participants
n=30 Participants
|
6 Participants
n=10 Participants
|
24 Participants
n=40 Participants
|
|
Urgent status at Transplant
|
26 Participants
n=30 Participants
|
9 Participants
n=10 Participants
|
35 Participants
n=40 Participants
|
|
Pre-transplant Pregnancy in Females
|
11 Participants
n=12 Participants • Only females were analyzed as this is a pregnancy metric
|
0 Participants
n=1 Participants • Only females were analyzed as this is a pregnancy metric
|
11 Participants
n=13 Participants • Only females were analyzed as this is a pregnancy metric
|
|
Pre-transplant Durable Mechanical Circulatory Support placement
|
6 Participants
n=30 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=40 Participants
|
|
Pre-transplant Panel Reactive Antibody ≥ 10%
|
6 Participants
n=30 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=40 Participants
|
|
Total time on transplant waitlist (Days, Median [Q1-Q3])
|
13 Days
n=30 Participants
|
12 Days
n=10 Participants
|
12 Days
n=40 Participants
|
|
Ischemic time (Minutes, Median [Q1-Q3])
|
192 Minutes
n=30 Participants
|
192 Minutes
n=10 Participants
|
192 Minutes
n=40 Participants
|
|
Transplant Operating Room Total Time (Minutes, Median [Q1-Q3])
|
536 Minutes
n=30 Participants
|
461 Minutes
n=10 Participants
|
461 Minutes
n=40 Participants
|
|
Recipient Aortic Cross-clamping Total Time (Minutes, Median [Q1-Q3])
|
99.5 Minutes
n=30 Participants
|
80 Minutes
n=10 Participants
|
80 Minutes
n=40 Participants
|
|
Recipient Cardiopulmonary Bypass Total Time (Minutes, Median [Q1-Q3])
|
149.5 Minutes
n=30 Participants
|
142 Minutes
n=10 Participants
|
142 Minutes
n=40 Participants
|
|
Pre-transplant Blood Transfusion
|
6 Participants
n=30 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 30 days post-heart transplantThe 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
Outcome measures
| Measure |
DBD Donor Heart Transplantation
n=30 Participants
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
DCD Donor Heart Transplantation
n=10 Participants
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.
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.
|
DCD OCS
DCD OCS
|
|---|---|---|---|
|
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.
Primary graft failure requiring re-transplantation
|
0 Participants
|
0 Participants
|
—
|
|
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.
Heart Graft-Related Serious Adverse Event (HGRSAE) in the first 30 days post-transplant
|
5 Participants
|
1 Participants
|
—
|
|
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.
Patient and graft survival at 30-days post-transplant
|
30 Participants
|
10 Participants
|
—
|
|
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.
Patient and graft survival at 30-days and initial hospital discharge, if later than 30 days
|
30 Participants
|
10 Participants
|
—
|
|
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.
Moderate or Severe Primary Graft Dysfunction
|
5 Participants
|
1 Participants
|
—
|
|
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.
Use of post-transplant Mechanical Circulatory Support(ECMO, LVAD, RVAD, BiVAD)
|
1 Participants
|
1 Participants
|
—
|
|
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.
30-day freedom from Any-treated Rejection
|
27 Participants
|
9 Participants
|
—
|
|
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.
30-day freedom from Acute Cellular Rejection (grade≥ 2R)
|
30 Participants
|
10 Participants
|
—
|
|
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.
30-day freedom from Antibody-mediated rejection (pAMR≥1)
|
27 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post transplantPrimary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS
Outcome measures
| Measure |
DBD Donor Heart Transplantation
n=30 Participants
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
DCD Donor Heart Transplantation
n=8 Participants
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.
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.
|
DCD OCS
n=2 Participants
DCD OCS
|
|---|---|---|---|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Use of post transplant Mechanical Circulatory Support (ECMO, LVAD, RVAD, BiVAD)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
30-day freedom from any-treated Rejection
|
27 Participants
|
8 Participants
|
1 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
30-day freedom from Acute Cellular Rejection (grade≥ 2R)
|
30 Participants
|
8 Participants
|
2 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
30-day freedom from Antibody-mediated rejection (pAMR≥1)
|
27 Participants
|
8 Participants
|
1 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Moderate or Severe Primary Graft Dysfunction
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Primary graft failure requiring re-transplantation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Heart Graft-Related Serious Adverse Event (HGRSAE) in the first 30 days post-transplant
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Patient and graft survival at 30-days post-transplant
|
30 Participants
|
8 Participants
|
2 Participants
|
|
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
Patient and graft survival at 30-days
|
30 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Time on waitlistThe 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.
Outcome measures
| Measure |
DBD Donor Heart Transplantation
n=30 Participants
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
DCD Donor Heart Transplantation
n=8 Participants
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.
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.
|
DCD OCS
n=2 Participants
DCD OCS
|
|---|---|---|---|
|
The Secondary Objective is to Assess the Practical, Financial and Logical Viability of Using NRP vs. DPP for the Procurement of DCD Donor Hearts
|
13 Days
Interval 6.25 to 37.0
|
8.5 Days
Interval 5.25 to 23.5
|
14 Days
Interval 13.5 to 14.5
|
Adverse Events
DBD Donor Heart Transplantation
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
DCD Donor Heart Transplantation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DBD Donor Heart Transplantation
n=30 participants at risk
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
DBD Donor Heart Transplantation: A technique of donor heart procurement.
|
DCD Donor Heart Transplantation
n=10 participants at risk
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.
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.
|
|---|---|---|
|
Cardiac disorders
Primary Graft Dysfunction (PGD)
|
16.7%
5/30 • Number of events 5 • All heart graft-related serious adverse events are to be recorded on the electronic case report forms until post-transplant day 30 and up until discharge, maximum 88 days.
Only Serious Adverse Events (SAEs) and Heart Graft-Related Adverse Events (HGRAEs) will be captured in this study in a DCD vs. DBD specifically in a pre-specified reporting manner.
|
10.0%
1/10 • Number of events 1 • All heart graft-related serious adverse events are to be recorded on the electronic case report forms until post-transplant day 30 and up until discharge, maximum 88 days.
Only Serious Adverse Events (SAEs) and Heart Graft-Related Adverse Events (HGRAEs) will be captured in this study in a DCD vs. DBD specifically in a pre-specified reporting manner.
|
|
Cardiac disorders
Use of post-transplant mechanical circulatory support for > 72 hours immediately post-transplant
|
3.3%
1/30 • Number of events 1 • All heart graft-related serious adverse events are to be recorded on the electronic case report forms until post-transplant day 30 and up until discharge, maximum 88 days.
Only Serious Adverse Events (SAEs) and Heart Graft-Related Adverse Events (HGRAEs) will be captured in this study in a DCD vs. DBD specifically in a pre-specified reporting manner.
|
10.0%
1/10 • Number of events 1 • All heart graft-related serious adverse events are to be recorded on the electronic case report forms until post-transplant day 30 and up until discharge, maximum 88 days.
Only Serious Adverse Events (SAEs) and Heart Graft-Related Adverse Events (HGRAEs) will be captured in this study in a DCD vs. DBD specifically in a pre-specified reporting manner.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place