The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Status: Completed
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• • 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.
Locations
United States
California
University of California San Diago
La Jolla
Cedars Sinai
Los Angeles
Stanford University
Palo Alto
Connecticut
Yale New Haven Hospital
New Haven
Florida
Mayo Clinic Florida
Jacksonville
AdventHealth Orlando
Orlando
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Illinois
Northwestern University
Evanston
Indiana
St. Vincent Cardiovascular Research Institute
Indianapolis
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Minnesota
Minneapolis Heart Institute
Minneapolis
University of Minnesota
Minneapolis
North Carolina
Duke University
Durham
Nebraska
University of Nebraska Medical Center
Omaha
New York
Montefiore
Bronx
Nyph/Cumc
New York
Westchester Medical Center
Valhalla
Tennessee
Vanderbilt University Medical Center
Nashville
Virginia
Sentara
Norfolk
Virginia Commonwealth University
Richmond
Wisconsin
University of Wisconsin
Madison
Froedtert & the Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2020-11-25
Completion Date: 2022-06-29
Participants
Target number of participants: 90
Treatments
Experimental: OCS Preservation
Authors
Ashish Shah, Gregory Couper, Fardad Esmailian, Jonathan Philpott, Koji Takeda, John Um, Christopher Salerno, Mohammed Quader, Karol Mudy, Hari R Mallidi, David Joyce, Yoshifumi Naka, Duc Thinh Pham, Yasuhiro Shudo, Andrew Shaffer, Jacob Schroder, Daniel Goldstein, Lucian Lozonschi, John Dunning, Arnar Geirsson, Si Pham, Scott Silvestry, Mani Daneshmand, Masashi Kai
Related Therapeutic Areas
Sponsors
Leads: TransMedics