Study Results
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View full resultsBasic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2019-11-26
2021-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCD Heart Possible
OCS Heart System
Preserving and assessing donor after circulatory death hearts for transplant
Standard of Care Heart Only
Cold Storage
Active comparator intervention
Interventions
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OCS Heart System
Preserving and assessing donor after circulatory death hearts for transplant
Cold Storage
Active comparator intervention
Eligibility Criteria
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Inclusion Criteria
* Donor age 18-49 years old inclusive
* Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time 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.
Donor Exclusion
* Previous cardiac surgery
* Known coronary artery disease
* Cardiogenic shock or myocardial infarction, or
* Sustained terminal ejection fraction (EF) of ≤ 50%, or
* Significant valve disease except for competent bicuspid aortic valve
Recipient Inclusion
* 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' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.
Recipient Exclusion
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
* Multi-organ transplant
* Investigator unwilling to randomize to either arm.
18 Years
ALL
No
Sponsors
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TransMedics
INDUSTRY
Responsible Party
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Locations
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University of California San Diago
La Jolla, California, United States
Cedars Sinai
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
AdventHealth
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 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
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nyph/Cumc
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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sentara
Norfolk, Virginia, United States
Virgina Commonwealth University
Richmond, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Merani S, Urban M, Westphal SG, Dong J, Miles CD, Maskin A, Hoffman A, Langnas AN. Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US. J Am Coll Surg. 2024 Jan 1;238(1):107-118. doi: 10.1097/XCS.0000000000000880. Epub 2023 Sep 29.
Schroder JN, Patel CB, DeVore AD, Bryner BS, Casalinova S, Shah A, Smith JW, Fiedler AG, Daneshmand M, Silvestry S, Geirsson A, Pretorius V, Joyce DL, Um JY, Esmailian F, Takeda K, Mudy K, Shudo Y, Salerno CT, Pham SM, Goldstein DJ, Philpott J, Dunning J, Lozonschi L, Couper GS, Mallidi HR, Givertz MM, Pham DT, Shaffer AW, Kai M, Quader MA, Absi T, Attia TS, Shukrallah B, Sun BC, Farr M, Mehra MR, Madsen JC, Milano CA, D'Alessandro DA. Transplantation Outcomes with Donor Hearts after Circulatory Death. N Engl J Med. 2023 Jun 8;388(23):2121-2131. doi: 10.1056/NEJMoa2212438.
Shudo Y, Benjamin-Addy R, Koyano TK, Hiesinger W, MacArthur JW, Woo YJ. Donors after circulatory death heart trial. Future Cardiol. 2021 Jan;17(1):11-17. doi: 10.2217/fca-2020-0070. Epub 2020 Jul 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OCS-CAR-03202019
Identifier Type: -
Identifier Source: org_study_id
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