Heart Transplant
Conditions
Keywords
Heart preservation, Beating heart transplant
Brief summary
To evaluate the effectiveness 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.
Detailed description
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 \[SOC1\] and Standard of Care 2 \[SOC2\] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
Interventions
Preserving and assessing donor after circulatory death hearts for transplant
Active comparator intervention
Sponsors
Study design
Eligibility
Inclusion criteria
Donor Inclusion * Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST) * Donor age 18-49 years old inclusive * Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor. Donor Exclusion * Previous cardiac surgery * Known coronary artery disease * Cardiogenic shock or myocardial infarction, or * Sustained terminal ejection fraction (EF) of ≤ 50%, or * Significant valve disease except for competent bicuspid aortic valve Recipient Inclusion * Primary heart transplant candidates * Age ≥ 18 years old * Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data. Recipient Exclusion * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal insufficiency * Multi-organ transplant * Investigator unwilling to randomize to either arm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 6 months | Patient survival 6 months post-transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utilization Rate | Within 24 hours post-transplant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DCD Heart OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant | 90 |
| Standard of Care Heart Cold Storage: Active comparator intervention | 90 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 9 |
| Overall Study | Protocol Violation | 9 | 3 |
| Overall Study | Protocol violation and death | 1 | 1 |
| Overall Study | Re-transplant | 0 | 2 |
Baseline characteristics
| Characteristic | Standard of Care Heart | Total | DCD Heart |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11.4 | 52.9 years STANDARD_DEVIATION 12.8 | 51.3 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 48 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 66 Participants | 128 Participants | 62 Participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 66 Participants | 132 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 90 | 10 / 90 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 67 / 90 | 0 / 0 |
Outcome results
Survival
Patient survival 6 months post-transplant
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCD Heart | Survival | 76 Participants |
| Standard of Care Heart | Survival | 75 Participants |
Utilization Rate
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.
Time frame: Within 24 hours post-transplant
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| DCD Heart | Utilization Rate | 80 Hearts Instrumented |