US National OCS Heart Perfusion (OHP) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OCS Heart.
- Who it may be relevant to
- Registry conditions: Heart Transplant. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
Detailed description
The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.
The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.
Interventions
- Device OCS Heart
The 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.
Primary outcome measures
- Recipients' patient and graft survival [Time frame: Up to 5 years post-transplant]
Eligibility criteria
Inclusion criteria
- N/A
Exclusion criteria
- N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 37 centers
- Banner University Medical Center Phoenix — Phoenix
- University of California San Diego — La Jolla
- Lucile Packard Children's Hospital Stanford — Palo Alto
- Stanford University — Palo Alto
- University of California San Francisco — San Francisco
- Boulder — Boulder
- Yale New Haven Hospital — New Haven
- Mayo Clinic Florida — Jacksonville
- … and 29 more centers
Identifiers
NCT: NCT05915299 · OCS-HEART-OHP-II