An observational study in Transplant, sponsored by TransMedics. Active, not recruiting at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by TransMedics · Observational
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.
Multi-center, observational post-approval registry to:
TransMedics is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.
Inclusion Criteria:
Recipient Exclusion Criteria:
Donor Exclusion Criteria (for DCD Donor Hearts only):
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
Device: OCS Heart System
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).
Device: OCS Heart System
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).
Device: OCS 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.
Patient Survival
Patient survival at one-year post-heart transplant.
Time frame: One year post-heart transplant
Safety Endpoint
Heart graft survival at 6 months post-heart transplant.
Time frame: 6 months post-heart transplant
Long Term Patient Survival
K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant
Time frame: 5 years post-heart transplant
Long Term Graft Survival
K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant
Time frame: 5 years post-heart transplant
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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