Recruiting

Observational StudyUS National OCS Heart Perfusion (OHP) Registry

Sponsor:

TransMedics

Code:

NCT05915299

Conditions

Heart Transplant

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

OCS Heart

Study Details

Brief summary:

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

Conditions

Heart Transplant

Study ID

NCT05915299

Start date

Aug 25, 2023

Status verified date

Sep, 2025

Completion date

Aug 31, 2033

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Exclusion Criteria:

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

OCS Heart Transplant Recipients

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.

Interventions

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.

Primary outcome measure

Recipients' patient and graft survival [ Time Frame: Up to 5 years post-transplant ]

Central Contacts and Locations

Central contacts

Raicca Haqqi

9788090620 rhaqqi@transmedics.com

Kausar Qidwai

kqidwai@transmedics.com

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Francisco Arabia, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Andrew Stewart

858-534-3793 a9stewart@health.ucsd.edu

Principal Investigator:

Victor Pretorius, MD

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Michael Ma, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Tiffany Koyano

650-724-6921 tkoyano3@stanford.edu

Principal Investigator:

Yasuhiro Shudo, MD, PhD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Cassie Nguyen

415-353-9124 cassie.nguyen@ucsf.edu

Cherry Ng

cherry.ng@ucsf.edu

Principal Investigator:

Liviu Klein, MD

Boulder

Recruiting

Boulder, Colorado, United States, 80309

Principal Investigator:

Jordan Hoffmans, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Wasima Shinwari

518-414-0322 wasima.shinwari@yale.edu

Principal Investigator:

Muhammad Anwer, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Mauricia Buchanan

904-953-9455 Buchanan.Mauricia@mayo.edu

Principal Investigator:

Basar Sareyyupoglu, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Courtney Nicholas

813-844-4914 courtneynicholas@tgh.org

Principal Investigator:

Lucian Lozonschi, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sara Hobbs

941-465-0829 shobbs3@emory.edu

Principal Investigator:

Joshua Chan, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Kayla Moore

773-702-8228 kaymoore@bsd.uchicago.edu

Principal Investigator:

Christopher Salerno, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Jennifer Isaacs

859-323-4738 jennifer.isaacs@uky.edu

Principal Investigator:

Matthias Loebe, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Gaurav Das

Gaurav.Das@tuftsmedicine.org

Principal Investigator:

Gregory Couper, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kamila Drezek

617-724-2610 KDREZEK@mgh.harvard.edu

Principal Investigator:

David D'Alessandro, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Debbie Conboy

617-632-8135 dconboy@bidmc.harvard.edu

Principal Investigator:

Masash Kai, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

China Green

chjgreen@med.umich.edu

Amanda Kasperek

7349369664 kasperea@med.umich.edu

Principal Investigator:

Jonathan Haft, MD

Henry Ford

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Matthew Callaghan

313-916-4596 mcallag2@hfhs.org

Principal Investigator:

Celeste Williams, MD

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Molly Fuller

612-863-7493 Molly.Fuller@allina.com

Principal Investigator:

Benjamin Sun, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Monica Myers

612-301-1175 myer0215@umn.edu

Principal Investigator:

Andrew Shaffer, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Deborah Rolbiecki

507-255-5027 rolbiecki.deborah@mayo.edu

Jolene Erola

Erola.Jolene@mayo.edu

Principal Investigator:

Mauricio Villavicencio, MD

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Favio Herbas

Favio.Herbas@mountsinai.org

Principal Investigator:

Anelechi Anyanwu, MD

Columbia University Irving Medical Center/ New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Bo Lu

bl2699@cumc.columbia.edu

Principal Investigator:

Koji Takeda, MD

Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Agnieszka Siemienik

asiemien@montefiore.org

Principal Investigator:

Daniel Goldstein, MD

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Corazon DeLaPena

Corazon.DeLaPena@wmchealth.org

Principal Investigator:

David Spielvogel, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 48109

Contacts

Briana Clark

919-966-7108 bdclark2@email.unc.edu

Principal Investigator:

Aurelie Merlo, MD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Susan Bernardo

Susan.Bernardo@atriumhealth.org

Principal Investigator:

Eric Skipper, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Sarah Casalinova

919-613-5621 sarah.casalinova@duke.edu

Principal Investigator:

Jacob Schroder, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Robert Hooker, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Gail Wallen

412-647-2782 walleng@upmc.edu

Principal Investigator:

David Kaczorowski, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Morgan Overstreet

843-792-8896 overstrm@musc.edu

Principal Investigator:

Arman Kilic, MD

Baylor Scott and White

Recruiting

Dallas, Texas, United States, 75226

Contacts

Lesia Parker

214-820-4836 Lesia.Parker@BSWHealth.org

Principal Investigator:

Dan Meyer, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Hadi Beaini

214-648-9472 Hadi.Beaini@UTSouthwestern.edu

Principal Investigator:

Maryjane Farr, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Ashley Elmer

801-585-6775 Ashley.Elmer@hsc.utah.edu

Principal Investigator:

Craig Selzman, MD

Virginia Commonwealth University Health

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

Mohammed Quader, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98105

Contacts

Shauna Andrus

206-953-9970 sandrus@uw.edu

Principal Investigator:

Jay Pal, MD

Aurora St Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Jillian Lux

Jillian.Lux@aah.org

Principal Investigator:

Nasir Sulemanjee, MD

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kelly Potzner

kpotzner@mcw.edu

Principal Investigator:

Lucian Durham, MD

More Information

Sponsor

TransMedics

Last update posted

Oct 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by TransMedics on 2025-10-30.