Heart TransplantNCT05741723
OCS DCD Heart + CAP Continued Follow-Up
An observational study of Heart Transplant, run by TransMedics at 20 sites in United States.
Trial summary
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- OCS Heart
- Type of treatment
- Medical device
- How many people
- 276 participants
- Where
- 20 sitesUnited States
- Study dates
- 26 Nov 2019to Oct 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.
Who may be able to join
- Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University Hospital
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medicine
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of California San Diago
La Jolla, California, 92037
University of Wisconsin
Madison, Wisconsin, 53792
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55414
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06510
Nyph/Cumc
New York, New York, 10032
Sentara
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
Montefiore
The Bronx, New York, 10467
About this study
Official title: OCS DCD Heart + CAP Continued Follow-Up Post-Approval Study
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.
- Conditions
- Heart Transplant
- 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
Transplanted with OCS preserved heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Patient survival through 5 years post-transplant
Measured: 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.
- First posted23 Feb 2023
- Study start26 Nov 2019
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 276 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741723
- Sponsor's protocol ID
- OCS-HEART-03-PAS
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS DCD Heart + CAP Continued Follow-Up Post-Approval Study
- ClinicalTrials.gov ID
- NCT05741723
- Acronym / sponsor ID
- OCS-HEART-03-PAS
- Conditions
- Heart Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.
Key inclusion criteria (1 listed)
- Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCS HeartTransplanted with OCS preserved heart. | Device | – |
Primary outcome
Patient survival
Time frame: 5 years post-transplant
Patient survival through 5 years post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by TransMedics at 20 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 0 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: 5 years post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.