Trial Outcomes & Findings for International EXPAND Heart Pivotal Trial (NCT NCT02323321)
NCT ID: NCT02323321
Last Updated: 2025-01-17
Results Overview
A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
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 Preservation and Assessment
Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
OCS Preservation
OCS Preservation and Assessment
Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
|
|---|---|
|
Overall Study
Re-Transplant
|
1
|
|
Overall Study
Death
|
12
|
Baseline Characteristics
International EXPAND Heart Pivotal Trial
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
|
|---|---|
|
Age, Continuous
|
55.46 years
STANDARD_DEVIATION 12.556 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 DaysA composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
Outcome measures
| Measure |
OCS Preservation
n=75 Participants
OCS Preservation and Assessment
Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
|
|---|---|
|
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
|
66 Participants
|
Adverse Events
OCS Preservation
Serious events: 56 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
OCS Preservation
n=75 participants at risk
OCS Preservation and Assessment
Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
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.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
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.
|
|
Cardiac disorders
Atrial fibrillation
|
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.
|
|
Cardiac disorders
Atrial flutter
|
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.
|
|
Cardiac disorders
Atrial tachycardia
|
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.
|
|
Cardiac disorders
Atrioventricular block
|
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.
|
|
Cardiac disorders
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.
|
|
Cardiac disorders
Cardiac failure congestive
|
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.
|
|
Cardiac disorders
Cor pulmonale
|
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.
|
|
Cardiac disorders
Electromechanical dissociation
|
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.
|
|
Cardiac disorders
Left ventricular dysfunction
|
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.
|
|
Cardiac disorders
Left ventricular 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.
|
|
Cardiac disorders
Nodal rhythm
|
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.
|
|
Cardiac disorders
Pericardial effusion
|
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.
|
|
Cardiac disorders
Right ventricular dysfunction
|
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.
|
|
Cardiac disorders
Right ventricular 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.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
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.
|
|
General disorders
Multi-organ 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.
|
|
Hepatobiliary disorders
Hepatic 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.
|
|
Immune system disorders
Heart transplant rejection
|
16.0%
12/75 • Number of events 12 • 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.
|
|
Infections and infestations
Clostridial infection
|
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.
|
|
Infections and infestations
H1N1 influenza
|
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.
|
|
Infections and infestations
Pneumonia
|
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.
|
|
Infections and infestations
Sepsis
|
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.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
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.
|
|
Injury, poisoning and procedural complications
Heart injury
|
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.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
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.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
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.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
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.
|
|
Injury, poisoning and procedural complications
Rectal laceration postoperative
|
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.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
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
Fluid overload
|
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
Cerebrovascular accident
|
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.
|
|
Nervous system disorders
Convulsion
|
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.
|
|
Nervous system disorders
Vocal cord paralysis
|
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
|
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.
|
|
Renal and urinary disorders
Renal failure acute
|
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
Renal impairment
|
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
Acute respiratory distress syndrome
|
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
Acute respiratory failure
|
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
Hydrothorax
|
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
|
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
Pleural effusion
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
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
|
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.
|
|
Vascular disorders
Haemorrhage
|
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
Subclavian vein thrombosis
|
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.
|
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