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OCS Heart Perfusion Post-Approval Registry
Sponsor: TransMedics
Summary
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
Official title: OCS Heart Perfusion (OHP) Post-Approval Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2021-09-13
Completion Date
2029-12
Last Updated
2025-10-30
Healthy Volunteers
No
Conditions
Interventions
OCS Heart System
The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. 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.
Locations (27)
Cedars Sinai
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States
Montefiore
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Duke University
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott and White
Dallas, Texas, United States
Medical City Dallas
Dallas, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States