Transplant
Conditions
Brief summary
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
Detailed description
Multi-center, observational post-approval registry to: 1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and 2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
Interventions
DEVICEOCS Heart System
The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.
Sponsors
TransMedics
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System. Recipient
Exclusion criteria
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant. Donor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | One year post-heart transplant | Patient survival at one-year post-heart transplant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 6 months post-heart transplant | Heart graft survival at 6 months post-heart transplant. |
| Long Term Patient Survival | 5 years post-heart transplant | K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant |
| Long Term Graft Survival | 5 years post-heart transplant | K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant |
Countries
United States
Outcome results
None listed