Clinical Trial

Enhancing Heart Allograft Function With the OCS Heart System Trial

Study acronym: ENHANCE
Recruiting
View on ClinicalTrials.gov →
Summary
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-25; most recent amendment 2026-01-08.
Status change: Not Yet Recruiting → Recruiting 2026-01-08
Trial Details
NCT Number NCT07145515
Lead Sponsor TransMedics
Conditions Heart Transplant
Enrollment 655 participants
Start Date 2026-01
Primary Completion 2027-01-30 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-12