Clinical Trial

OCS Heart Perfusion Post-Approval Registry

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 30, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2021-09-08; most recent amendment 2025-10-29.
Status change: Recruiting → Active, Not Recruiting 2024-02-29
Status change: Not Yet Recruiting → Recruiting 2022-02-10
Trial Details
NCT Number NCT05047068
Lead Sponsor TransMedics
Conditions Transplant
Enrollment 350 participants
Start Date 2021-09-13
Primary Completion 2025-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-30