Trial Outcomes & Findings for Donor After Circulatory Death Heart CAP Trial (NCT NCT04615182)
NCT ID: NCT04615182
Last Updated: 2024-06-21
Results Overview
Patient survival at 6 months post-transplant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
6 months post-transplant
Results posted on
2024-06-21
Participant Flow
Participant milestones
| Measure |
OCS Preservation
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Overall Study
STARTED
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90
|
|
Overall Study
Per Protocol Population
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83
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
OCS Preservation
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Overall Study
Re-transplanted
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2
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Death
|
6
|
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Overall Study
Death and protocol violation
|
1
|
Baseline Characteristics
Donor After Circulatory Death Heart CAP Trial
Baseline characteristics by cohort
| Measure |
OCS Preservation
n=83 Participants
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Age, Continuous
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55.1 Years
STANDARD_DEVIATION 12.923 • n=5 Participants
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Sex: Female, Male
Female
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18 Participants
n=5 Participants
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Sex: Female, Male
Male
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65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 months post-transplantPopulation: Per protocol population reported. Two subjects were withdrawn due to re-transplant and were excluded from the analysis.
Patient survival at 6 months post-transplant.
Outcome measures
| Measure |
OCS Preservation
n=81 Participants
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Patient Survival
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75 Participants
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SECONDARY outcome
Timeframe: 24 hours post transplantPopulation: 95 eligible DCD donor hearts met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System.
Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol 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 |
OCS Preservation
n=95 Hearts Instrumented
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Utilization Rate
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83 Hearts Instrumented
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Adverse Events
OCS Preservation
Serious events: 53 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
OCS Preservation
n=90 participants at risk
Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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|---|---|
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Blood and lymphatic system disorders
Blood loss anaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Blood and lymphatic system disorders
Coagulopathy
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Atrial flutter
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Cardiac disorders
Cardiac tamponade
|
3.3%
3/90 • Number of events 3 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Left ventricular dysfunction
|
23.3%
21/90 • Number of events 21 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Pericardial effusion
|
5.6%
5/90 • Number of events 6 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Pericardial haemorrhage
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Right ventricular dysfunction
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Tricuspid valve incompetence
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Cardiac disorders
Ventricular fibrillation
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Gastrointestinal disorders
Gastritis
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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Gastrointestinal disorders
Impaired gastric emptying
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
General disorders
Pyrexia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Immune system disorders
Transplant rejection
|
10.0%
9/90 • Number of events 10 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Infections and infestations
COVID-19
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Infections and infestations
Clostridium difficile infection
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Infections and infestations
Fungaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Infections and infestations
Infection
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Infections and infestations
Pneumonia
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
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|
Infections and infestations
Sepsis
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Injury, poisoning and procedural complications
Injury
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Nervous system disorders
Vocal cord paralysis
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
10/90 • Number of events 10 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Renal and urinary disorders
Renal failure
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Renal and urinary disorders
Renal impairment
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.4%
4/90 • Number of events 4 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
3/90 • Number of events 3 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Vascular disorders
Haematoma
|
2.2%
2/90 • Number of events 2 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Vascular disorders
Haemorrhage
|
4.4%
4/90 • Number of events 4 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
1/90 • Number of events 1 • Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed, and therefore are not reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
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