Trial Outcomes & Findings for Heart EXPAND Continued Access Protocol (NCT NCT03835754)
NCT ID: NCT03835754
Last Updated: 2025-01-17
Results Overview
A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
30 days
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
OCS Preservation
OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
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|---|---|
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Overall Study
STARTED
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75
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Overall Study
COMPLETED
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71
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
OCS Preservation
OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
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Overall Study
Death
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4
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Baseline Characteristics
Heart EXPAND Continued Access Protocol
Baseline characteristics by cohort
| Measure |
OCS Preservation
n=75 Participants
OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
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|---|---|
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Age, Continuous
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54.0 Years
STANDARD_DEVIATION 13.3 • n=99 Participants
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Sex: Female, Male
Female
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17 Participants
n=99 Participants
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Sex: Female, Male
Male
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58 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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67 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 30 daysA composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
Outcome measures
| Measure |
OCS Preservation
n=75 Participants
OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
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|---|---|
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Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation
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72 Participants
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Adverse Events
OCS Preservation
Serious events: 44 serious events
Other events: 0 other events
Deaths: 71 deaths
Serious adverse events
| Measure |
OCS Preservation
n=75 participants at risk
OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Atrial fibrillation
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5.3%
4/75 • Number of events 4 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Cardiac arrest
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Cardiac tamponade
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Atrioventricular block complete
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Left ventricular dysfunction
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6.7%
5/75 • Number of events 5 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Pericardial effusion
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Right ventricular dysfunction
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6.7%
5/75 • Number of events 5 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Sinus bradycardia
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Cardiac disorders
Ventricular dysfunction
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8.0%
6/75 • Number of events 6 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Gastrointestinal disorders
Gastrointestinal haemorrhage
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Gastrointestinal disorders
Diarrhea
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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General disorders
Multi-organ failure
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Immune system disorders
Acute cellular rejection
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4.0%
3/75 • Number of events 3 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Immune system disorders
Acute graft rejection
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4.0%
3/75 • Number of events 3 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Infections and infestations
Bacteremia
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Infections and infestations
Escherichia coli infection
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Infections and infestations
Pneumonia
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2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Injury, poisoning and procedural complications
Drug toxicity
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Injury, poisoning and procedural complications
Mental status changes postoperative
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Injury, poisoning and procedural complications
Injury to inferior vena cava
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Metabolism and nutrition disorders
Dehydration
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Metabolism and nutrition disorders
Volume overload
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1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Nervous system disorders
Embolic stroke
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Nervous system disorders
Hemorrhagic stroke
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
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Nervous system disorders
Metabolic encephalopathy
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
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Nervous system disorders
Nerve pain
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Nervous system disorders
Stroke
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Psychiatric disorders
Delirium
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Psychiatric disorders
Psychosis
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
10/75 • Number of events 10 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Renal and urinary disorders
Acute tubular necrosis
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Renal and urinary disorders
Kidney dysfunction
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial mucus plug
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
4/75 • Number of events 4 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Vascular disorders
Aortic dissection
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Vascular disorders
Bleeding
|
10.7%
8/75 • Number of events 8 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Vascular disorders
Hematoma
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Vascular disorders
Hypotension
|
1.3%
1/75 • Number of events 1 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
|
Vascular disorders
Orthostatic hypotension
|
2.7%
2/75 • Number of events 2 • Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 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. Not Serious AEs were not collected, and therefore not reported.
|
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