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Heart TransplantNCT05915299

US National OCS Heart Perfusion (OHP) Registry

An observational study of Heart Transplant, run by TransMedics at 37 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Transplant
What is being tested?
OCS Heart
Type of treatment
Medical device
How many people
100,000 participants
Where
37 sitesUnited States
Study dates
25 Aug 2023to 31 Aug 2033
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • N/A

Who cannot join

  • N/A

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Raicca Haqqi contact

9788090620

rhaqqi@transmedics.com

Kausar Qidwai contact

kqidwai@transmedics.com

37 sites in 1 country

United States37 sites, 37 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    China Green, chjgreen@med.umich.edu

    Amanda Kasperek, 7349369664, kasperea@med.umich.edu

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Sara Hobbs, 941-465-0829, shobbs3@emory.edu

    Joshua Chan, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Gaurav Das, Gaurav.Das@tuftsmedicine.org

    Gregory Couper, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Kamila Drezek, 617-724-2610, KDREZEK@mgh.harvard.edu

    David D'Alessandro, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Debbie Conboy, 617-632-8135, dconboy@bidmc.harvard.edu

    Masash Kai, MD

    Recruiting

  • Boulder

    Boulder, Colorado, 80309

    Nargis Kalia, MPH

    Jordan Hoffmans, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 48109

    Briana Clark, 919-966-7108, bdclark2@email.unc.edu

    Aurelie Merlo, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Morgan Overstreet, 843-792-8896, overstrm@musc.edu

    Arman Kilic, MD

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28203

    Susan Bernardo, Susan.Bernardo@atriumhealth.org

    Eric Skipper, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Kayla Moore, 773-702-8228, kaymoore@bsd.uchicago.edu

    Christopher Salerno, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    William Stewart

    Robert Hooker, MD

    Recruiting

  • Baylor Scott and White

    Dallas, Texas, 75226

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

    Dan Meyer, MD

    Recruiting

  • University of Texas Southwestern

    Dallas, Texas, 75390

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

    Maryjane Farr, MD

    Recruiting

  • Henry Ford

    Detroit, Michigan, 48202

    Matthew Callaghan, 313-916-4596, mcallag2@hfhs.org

    Celeste Williams, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Sarah Casalinova, 919-613-5621, sarah.casalinova@duke.edu

    Jacob Schroder, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

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

    Basar Sareyyupoglu, MD

    Recruiting

  • University of California San Diego

    La Jolla, California, 92037

    Andrew Stewart, 858-534-3793, a9stewart@health.ucsd.edu

    Victor Pretorius, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40506

    Jennifer Isaacs, 859-323-4738, jennifer.isaacs@uky.edu

    Matthias Loebe, MD

    Recruiting

  • Aurora St Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Jillian Lux, Jillian.Lux@aah.org

    Nasir Sulemanjee, MD

    Recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kelly Potzner, kpotzner@mcw.edu

    Lucian Durham, MD

    Recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

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

    Benjamin Sun, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Monica Myers, 612-301-1175, myer0215@umn.edu

    Andrew Shaffer, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Wasima Shinwari, 518-414-0322, wasima.shinwari@yale.edu

    Muhammad Anwer, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Favio Herbas, Favio.Herbas@mountsinai.org

    Anelechi Anyanwu, MD

    Recruiting

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

    Bo Lu, bl2699@cumc.columbia.edu

    Koji Takeda, MD

    Recruiting

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California, 94304

    Tiffany Koyano

    Michael Ma, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Tiffany Koyano, 650-724-6921, tkoyano3@stanford.edu

    Yasuhiro Shudo, MD, PhD

    Recruiting

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Raelyn McGarry

    Francisco Arabia, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Gail Wallen, 412-647-2782, walleng@upmc.edu

    David Kaczorowski, MD

    Recruiting

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298

    Giorgi Mchedkushvili

    Jinfeng Han

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Deborah Rolbiecki, 507-255-5027, rolbiecki.deborah@mayo.edu

    Jolene Erola, Erola.Jolene@mayo.edu

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

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

    Craig Selzman, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94143

    Cassie Nguyen, 415-353-9124, cassie.nguyen@ucsf.edu

    Cherry Ng, cherry.ng@ucsf.edu

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, 98105

    Shauna Andrus, 206-953-9970, sandrus@uw.edu

    Jay Pal, MD

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Courtney Nicholas, 813-844-4914, courtneynicholas@tgh.org

    Lucian Lozonschi, MD

    Recruiting

  • Montefiore

    The Bronx, New York, 10467

    Agnieszka Siemienik, asiemien@montefiore.org

    Daniel Goldstein, MD

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Corazon DeLaPena, Corazon.DeLaPena@wmchealth.org

    David Spielvogel, MD

    Recruiting

Other trials in United States

About this study

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

Read the 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.

Being tested
OCS Heart

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCS HeartDevice

    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.

Study groups in NCT05915299
Study groupRoleWhat they receive
OCS Heart Transplant RecipientsAll heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry.
Receives: Device: OCS Heart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recipients' patient and graft survival

    Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.

    Measured: Up to 5 years post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start25 Aug 2023
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
100,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915299
Sponsor's protocol ID
OCS-HEART-OHP-II
Status last verified
Sep 2025
First submitted
13 Jun 2023
Last updated
30 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Transplant, run by TransMedics at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raicca Haqqi (9788090620, rhaqqi@transmedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recipients' patient and graft survival (time frame: Up to 5 years post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.

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