Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100000 participants
OBSERVATIONAL
2023-08-25
2033-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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OCS Heart Transplant Recipients
All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Locations
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Banner University Medical Center Phoenix
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
Boulder
Boulder, Colorado, 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
University of Chicago
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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Mount Sinai
New York, New York, 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
University of North Carolina
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Scott and White
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University Health
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Raelyn McGarry
Role: primary
Tiffany Koyano
Role: primary
Nargis Kalia, MPH
Role: primary
William Stewart
Role: primary
Giorgi Mchedkushvili
Role: primary
Jinfeng Han
Role: backup
Other Identifiers
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OCS-HEART-OHP-II
Identifier Type: -
Identifier Source: org_study_id
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