Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
TransMedics
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceOCS Heart
Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.
- OtherStatic Cold Storage (SCS)
Preservation of donor hearts with static cold storage.
Locations (8)
- University of California San FranciscoSan Francisco, California
- Tampa General HospitalTampa, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Mount SinaiNew York, New York
- Columbia University Irving Medical Center/ New York Presbyterian HospitalNew York, New York
- Westchester Medical CenterValhalla, New York