Donor After Circulatory Death Heart CAP Trial
- Conditions
- Heart Transplant
- Interventions
- Device: Transplant
- Registration Number
- NCT04615182
- Lead Sponsor
- TransMedics
- Brief Summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Detailed Description
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-
• Primary heart transplant candidates
- Age ≥ 18 years old
- Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
Recipient
-
Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCS Preservation Transplant -
- Primary Outcome Measures
Name Time Method Patient Survival 6 months post-transplant Patient survival at 6 months post-transplant.
- Secondary Outcome Measures
Name Time Method Utilization Rate 24 hours post transplant Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.
Trial Locations
- Locations (25)
Northwestern University
🇺🇸Evanston, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of California San Diago
🇺🇸La Jolla, California, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Nyph/Cumc
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Sentara
🇺🇸Norfolk, Virginia, United States
St. Vincent Cardiovascular Research Institute
🇺🇸Indianapolis, Indiana, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Froedtert & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Montefiore
🇺🇸Bronx, New York, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States