clinical trial · NCT05915299
US National OCS Heart Perfusion (OHP) Registry
TransMedics·—·recruiting·n = 100,000
Heart TransplantOCS Heart
brief summary
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
started
Aug 25, 2023
primary completion
Aug 31, 2029
completion
Aug 31, 2033
last updated
Oct 30, 2025
detailed description
The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.
The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol