OCS Heart Perfusion Post-Approval Registry
Purpose
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.
Condition
- Transplant
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 Exclusion Criteria (for DCD Donor Hearts only): - Warm ischemic time > 30 minutes (warm ischemic time is 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).
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| OCS DBD Heart Primary Analysis Population | 200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: - Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or - On renal dialysis at time of transplant |
|
| OCS DCD Heart Primary Analysis Population | 150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: - Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or - On renal dialysis at time of transplant - Transplanted with DCD heart with warm ischemic time > 30 minutes (warm ischemic time is 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). |
|
| Other OCS Heart Analysis Population | Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD). |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- TransMedics
Study Contact
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.