Enhancing Heart Allograft Function With the OCS Heart System Trial
ConditionHeart Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTransMedics
About this trial
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 criteria
Qualifiers
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
Donor age ≥ 40 years old
Unknown downtime
Disqualifiers
None
Trial design
Treatments tested in this trial
- OCS Heart
- Static Cold Storage (SCS)
Treatment groups
655 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov