Heart Transplant
Conditions
Brief summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Detailed description
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.
Interventions
DEVICETransplant
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.
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Inclusion Criteria: * • 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' UNOS/OPTN data and recipients' INTERMACS data. Recipient
Exclusion criteria
* Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal insufficiency * Multi-organ transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | 6 months post-transplant | Patient survival at 6 months post-transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utilization Rate | 24 hours post transplant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Death and protocol violation | 1 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Re-transplanted | 2 |
Baseline characteristics
| Characteristic | OCS Preservation |
|---|---|
| Age, Continuous | 55.1 Years STANDARD_DEVIATION 12.923 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 90 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 53 / 90 |
Outcome results
Primary
Patient Survival
Patient survival at 6 months post-transplant.
Time frame: 6 months post-transplant
Population: Per protocol population reported. Two subjects were withdrawn due to re-transplant and were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCS Preservation | Patient Survival | 75 Participants |
Secondary
Utilization Rate
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.
Time frame: 24 hours post transplant
Population: 95 eligible DCD donor hearts met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OCS Preservation | Utilization Rate | 83 Hearts Instrumented |