Status:
NOT_YET_RECRUITING
Enhancing Heart Allograft Function With the OCS Heart System Trial
Lead Sponsor:
TransMedics
Conditions:
Heart Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 additi...
Eligibility Criteria
Inclusion
- Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):
- Donor Inclusion Criteria
- Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
- DBD donor hearts with an expected cross clamp of ≥ 4 hours
- DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
- Donor age ≥ 40 years old
- Unknown downtime
- Insignificant CAD
- LVEF ≤ 50%
- Donor Exclusion • Moderate to severe aortic incompetence
- Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):
- Donor Inclusion Criteria
- Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
- Eligible for randomization to OCS or SCS treatment arms.
- DBD donor hearts with an expected cross clamp time of \< 4 hours.
- Donor Exclusion
- Moderate to severe aortic incompetence
- DBD donor with any of the following organ quality concerns:
- Donor age ≥ 40 years old
- Unknown downtime
- Insignificant CAD
- LVEF ≤ 50%
- Recipient Eligibility Criteria (for Part A and B Cohorts)
- Inclusion
- Signed informed consent document and authorization to use and disclose protected health information
- Heart transplant candidate
- Age ≥ 18 years old
- Exclusion
- • Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
Exclusion
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT07145515
Start Date
February 1 2026
End Date
July 30 2027
Last Update
November 25 2025
Active Locations (4)
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1
Mount Sinai
New York, New York, United States, 10029
2
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
3
Westchester Medical Center
Valhalla, New York, United States, 10595
4
Duke University
Durham, North Carolina, United States, 27710