Heart TransplantNCT03835754
Heart EXPAND Continued Access Protocol
A study testing OCS Heart System in people with Heart Transplant, run by TransMedics at 12 sites in United States.
Trial summary
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol. 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 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Apr 2019to 12 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of the following:
- Expected total cross-clamp time of ≥ 4 hours
- Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of >12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.
Who cannot join
- CAD with > 50% stenosis on angiogram, or
- Cardiogenic shock or myocardial infarction, or
- EF consistently < 40%, or
- Significant valve disease except for competent bicuspid aortic valve.
- Eligibility Criteria (RECIPIENT)
- Registered primary heart transplant candidate
Show all 11Show fewer
- Age >18 years old
- Written informed consent. Exclusion
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
- Multi-organ transplant.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260
Cedars-Sinai
Los Angeles, California, 90211
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06510
Nyph/Cumc
New York, New York, 10032
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Heart Expand Continued Access Protocol
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
Read the detailed description
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
- Conditions
- Heart Transplant
- Being tested
- OCS Heart System
- Keywords
- Heart preservation, Beating heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Heart SystemDevice
The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
| Study group | Role | What they receive |
|---|---|---|
| OCS Preservation | Experimental | Not described Receives: Device: OCS Heart System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation
A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start17 Apr 2019
- Primary completion15 Sep 2021
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835754
- Sponsor's protocol ID
- OCS-CAR-121918
- Status last verified
- Dec 2022
- First submitted
- 22 Jan 2019
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schroder JN, Patel CB, DeVore AD, Casalinova S, Koomalsingh KJ, Shah AS, Anyanwu AC, D'Alessandro DA, Mudy K, Sun B, Strueber M, Khaghani A, Shudo Y, Esmailian F, Liao K, Pagani FD, Silvestry S, Wang IW, Salerno CT, Absi TS, Madsen JC, Mancini D, Fiedler AG, Milano CA, Smith JW. Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial. JACC Heart Fail. 2024 Mar;12(3):438-447. doi: 10.1016/j.jchf.2023.11.015. Epub 2024 Jan 24.
PubMed 38276933
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Expand Continued Access Protocol
- ClinicalTrials.gov ID
- NCT03835754
- Acronym / sponsor ID
- OCS-CAR-121918
- Conditions
- Heart Transplant
- Keywords
- Heart preservation, Beating heart transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
Detailed description
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Preservation | Experimental | Device: OCS Heart System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Expected total cross-clamp time of ≥ 4 hours
- Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of >12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.
Key exclusion criteria (11 listed)
- CAD with > 50% stenosis on angiogram, or
- Cardiogenic shock or myocardial infarction, or
- EF consistently < 40%, or
- Significant valve disease except for competent bicuspid aortic valve.
- Eligibility Criteria (RECIPIENT)
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 Heart SystemThe OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment | Device | OCS Preservation |
Primary outcome
Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation
Time frame: 30 days
A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38276933Schroder JN, Patel CB, DeVore AD, Casalinova S, Koomalsingh KJ, Shah AS, Anyanwu AC, D'Alessandro DA, Mudy K, Sun B, Strueber M, Khaghani A, Shudo Y, Esmailian F, Liao K, Pagani FD, Silvestry S, Wang IW, Salerno CT, Absi TS, Madsen JC, Mancini D, Fiedler AG, Milano CA, Smith JW. Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial. JACC Heart Fail. 2024 Mar;12(3):438-447. doi: 10.1016/j.jchf.2023.11.015. Epub 2024 Jan 24.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Heart System in people with Heart Transplant, run by TransMedics at 12 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation (time frame: 30 days). 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 NCT03835754, which also lists 1 linked publication.
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 17 Jan 2025.