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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ACTIVE_NOT_RECRUITING
350 participants
OBSERVATIONAL
2021-09-13
2029-12-31
Brief Summary
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Detailed Description
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1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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OCS DBD Heart Primary Analysis Population
200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant
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.
OCS DCD Heart Primary Analysis Population
150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant
* Transplanted with DCD heart with warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
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.
Other OCS Heart Analysis Population
Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* On renal dialysis at time of transplant.
* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
18 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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OCSHEART-01-ClinPAS
Identifier Type: -
Identifier Source: org_study_id
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