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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OCS Heart
DevicePreservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.
Static Cold Storage (SCS)
Other interventionPreservation of donor hearts with static cold storage.
Treatment groups
655 Participants
are divided into 3 treatment groupsGroup A: Part A (OCS Heart)Experimental treatment 1 intervention
Group B: Part B (OCS Heart)Experimental treatment 1 intervention
Group C: Part B (SCS)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient and graft survival
The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.
Time frame
30-day post transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov