US National OCS Heart Perfusion (OHP) Registry
ConditionHeart Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTransMedics
About this trial
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
N/A
Disqualifiers
N/A
Trial population
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
OCS Heart
DeviceThe TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.
Treatment groups
100,000 Participants
are divided into 1 treatment groupGroup A: OCS Heart Transplant Recipients1 intervention
Trial outcomes
Primary outcomes
1
Recipients' patient and graft survival
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.
Time frame
Up to 5 years post-transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov