Trial Outcomes & Findings for Donors After Circulatory Death Heart Trial (NCT NCT03831048)
NCT ID: NCT03831048
Last Updated: 2024-05-07
Results Overview
Patient survival 6 months post-transplant
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
6 months
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
DCD Heart
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
Cold Storage: Active comparator intervention
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
Per Protocol Population
|
80
|
86
|
|
Overall Study
COMPLETED
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
| Measure |
DCD Heart
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
Cold Storage: Active comparator intervention
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
3
|
|
Overall Study
Death
|
4
|
9
|
|
Overall Study
Re-transplant
|
0
|
2
|
|
Overall Study
Protocol violation and death
|
1
|
1
|
Baseline Characteristics
Donors After Circulatory Death Heart Trial
Baseline characteristics by cohort
| Measure |
DCD Heart
n=90 Participants
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
n=90 Participants
Cold Storage: Active comparator intervention
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
55 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPatient survival 6 months post-transplant
Outcome measures
| Measure |
DCD Heart
n=80 Participants
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
n=86 Participants
Cold Storage: Active comparator intervention
|
|---|---|---|
|
Survival
|
76 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Within 24 hours post-transplantPopulation: Per protocol, Analysis Population includes DCD donor hearts that met the warm ischemic time limit, then were instrumented on OCS Heart System and transplanted. The utilization rate is analyzing only the number of hearts instrumented/transplanted, and not number of participants.
Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.
Outcome measures
| Measure |
DCD Heart
n=91 Hearts Instrumented
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
Cold Storage: Active comparator intervention
|
|---|---|---|
|
Utilization Rate
|
80 Hearts Instrumented
|
—
|
Adverse Events
DCD Heart
Serious events: 67 serious events
Other events: 0 other events
Deaths: 5 deaths
Standard of Care Heart
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
DCD Heart
n=90 participants at risk
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
|
Standard of Care Heart
Cold Storage: Active comparator intervention
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Cardiac tamponade
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Cardiogenic shock
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Left ventricular dysfunction
|
17.8%
16/90 • Number of events 16 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Pericardial effusion
|
4.4%
4/90 • Number of events 4 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Pericardial haemorrhage
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Right ventricular dysfunction
|
6.7%
6/90 • Number of events 6 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Gastrointestinal disorders
Volvulus
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Immune system disorders
Transplant rejection
|
20.0%
18/90 • Number of events 18 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Bacteraemia
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Endocarditis
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Fungal infection
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Pneumonia
|
5.6%
5/90 • Number of events 5 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Infections and infestations
Sepsis
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Nervous system disorders
Brain hypoxia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Nervous system disorders
Migraine
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Nervous system disorders
Seizure
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Nervous system disorders
Spinal stroke
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Psychiatric disorders
Delirium
|
2.2%
2/90 • Number of events 2 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
15/90 • Number of events 15 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Renal and urinary disorders
Renal failure
|
4.4%
4/90 • Number of events 4 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
3/90 • Number of events 3 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
6/90 • Number of events 6 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/90 • Number of events 1 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
|
Vascular disorders
Haemorrhage
|
11.1%
10/90 • Number of events 10 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
—
0/0 • Per the protocol, all SAEs will be collected for the first 30 days post-transplant for the DCD Heart Transplanted Recipients group only. All-Cause Mortality was assessed for 6 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study for the DCD Heart Transplanted Recipients group. SAEs and HGRSAEs will not be captured for the Standard of Care Heart Transplanted Recipient group.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER