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Purpose

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • N/A

Exclusion Criteria

  • N/A

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
OCS Heart Transplant Recipients All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
  • Device: OCS Heart
    The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. 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.

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Raelyn McGarry

University of California San Diego
La Jolla, California 92037
Contact:
Andrew Stewart
858-534-3793
a9stewart@health.ucsd.edu

Lucile Packard Children's Hospital Stanford
Palo Alto, California 94304
Contact:
Tiffany Koyano

Stanford University
Palo Alto, California 94304
Contact:
Tiffany Koyano
650-724-6921
tkoyano3@stanford.edu

University of California San Francisco
San Francisco, California 94143
Contact:
Cassie Nguyen
415-353-9124
cassie.nguyen@ucsf.edu

Boulder
Boulder, Colorado 80309
Contact:
Nargis Kalia, MPH

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Wasima Shinwari
518-414-0322
wasima.shinwari@yale.edu

Mayo Clinic Florida
Jacksonville, Florida 32224
Contact:
Mauricia Buchanan
904-953-9455
Buchanan.Mauricia@mayo.edu

Tampa General Hospital
Tampa, Florida 33606
Contact:
Courtney Nicholas
813-844-4914
courtneynicholas@tgh.org

Emory University Hospital
Atlanta, Georgia 30322
Contact:
Sara Hobbs
941-465-0829
shobbs3@emory.edu

University of Chicago
Chicago, Illinois 60637
Contact:
Kayla Moore
773-702-8228
kaymoore@bsd.uchicago.edu

University of Kentucky
Lexington, Kentucky 40506
Contact:
Jennifer Isaacs
859-323-4738
jennifer.isaacs@uky.edu

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Gaurav Das
Gaurav.Das@tuftsmedicine.org

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kamila Drezek
617-724-2610
KDREZEK@mgh.harvard.edu

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Debbie Conboy
617-632-8135
dconboy@bidmc.harvard.edu

University of Michigan
Ann Arbor, Michigan 48109
Contact:
China Green
chjgreen@med.umich.edu

Henry Ford
Detroit, Michigan 48202
Contact:
Matthew Callaghan
313-916-4596
mcallag2@hfhs.org

Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Contact:
Molly Fuller
612-863-7493
Molly.Fuller@allina.com

University of Minnesota
Minneapolis, Minnesota 55414
Contact:
Monica Myers
612-301-1175
myer0215@umn.edu

Mayo Clinic Rochester
Rochester, Minnesota 55905
Contact:
Deborah Rolbiecki
507-255-5027
rolbiecki.deborah@mayo.edu

Mount Sinai
New York, New York 10029
Contact:
Favio Herbas
Favio.Herbas@mountsinai.org

Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York 10032
Contact:
Bo Lu
bl2699@cumc.columbia.edu

Montefiore
The Bronx, New York 10467
Contact:
Agnieszka Siemienik
asiemien@montefiore.org

Westchester Medical Center
Valhalla, New York 10595
Contact:
Corazon DeLaPena
Corazon.DeLaPena@wmchealth.org

University of North Carolina
Chapel Hill, North Carolina 48109
Contact:
Briana Clark
919-966-7108
bdclark2@email.unc.edu

Atrium Health
Charlotte, North Carolina 28203
Contact:
Susan Bernardo
Susan.Bernardo@atriumhealth.org

Duke University
Durham, North Carolina 27710
Contact:
Sarah Casalinova
919-613-5621
sarah.casalinova@duke.edu

The Christ Hospital
Cincinnati, Ohio 45219
Contact:
William Stewart

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Gail Wallen
412-647-2782
walleng@upmc.edu

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Baylor Scott and White
Dallas, Texas 75226
Contact:
Lesia Parker
214-820-4836
Lesia.Parker@BSWHealth.org

University of Texas Southwestern
Dallas, Texas 75390
Contact:
Hadi Beaini
214-648-9472
Hadi.Beaini@UTSouthwestern.edu

University of Utah
Salt Lake City, Utah 84132
Contact:
Ashley Elmer
801-585-6775
Ashley.Elmer@hsc.utah.edu

Virginia Commonwealth University Health
Richmond, Virginia 23298
Contact:
Giorgi Mchedkushvili

University of Washington Medical Center
Seattle, Washington 98105
Contact:
Shauna Andrus
206-953-9970
sandrus@uw.edu

Aurora St Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Jillian Lux
Jillian.Lux@aah.org

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Kelly Potzner
kpotzner@mcw.edu

More Details

NCT ID
NCT05915299
Status
Recruiting
Sponsor
TransMedics

Study Contact

Raicca Haqqi
9788090620
rhaqqi@transmedics.com

Detailed Description

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US. The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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