OCS Heart Perfusion Post-Approval Registry
- Conditions
- Transplant
- Interventions
- Device: OCS Heart System
- Registration Number
- NCT05047068
- Lead Sponsor
- TransMedics
- Brief 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.
- Detailed Description
Multi-center, observational post-approval registry to:
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient
- Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- On renal dialysis at time of transplant.
Donor Exclusion Criteria (for DCD Donor Hearts only):
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Other OCS Heart Analysis Population OCS Heart System 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 DBD Heart Primary Analysis Population OCS Heart System 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 DCD Heart Primary Analysis Population OCS Heart System 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).
- Primary Outcome Measures
Name Time Method Patient Survival One year post-heart transplant Patient survival at one-year post-heart transplant.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Cedars Sinai
🇺🇸Los Angeles, California, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Stanford University
🇺🇸Palo Alto, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, 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
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Montefiore
🇺🇸Bronx, New York, United States
Nyph/Cumc
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Baylor Scott and White
🇺🇸Dallas, Texas, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Froedtert & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States