Heart TransplantEXPANDHeartNCT02323321
International EXPAND Heart Pivotal Trial
A study testing Preservation of Hearts for Transplantation in people with Heart Transplant, run by TransMedics at 11 sites in United States.
Trial summary
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation 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?
- Preservation of Hearts for Transplantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Sep 2015to 2 Mar 2019
- 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
- Registered male or female primary Heart transplant candidate
- Age ≥18 years old
Who cannot join
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan
Massachusetts General Hospital
Boston, Massachusetts
Duke University Medical Center
Durham, North Carolina
Spectrum Health
Grand Rapids, Michigan
Indiana University
Indianapolis, Indiana, 46202
Cedars-Sinai Medical Center
Los Angeles, California, 90211
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center
Minneapolis, Minnesota
Vanderbilt University Medical Center
Nashville, Tennessee
Mount Sinai
New York, New York, 10029
University of Washington Medical Center
Seattle, Washington, 98105
About this study
Official title: International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation
- Conditions
- Heart Transplant
- Being tested
- Preservation of Hearts for Transplantation
- Keywords
- heart transplant, heart preservation, beating heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservation of Hearts for TransplantationDevice
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
| Study group | Role | What they receive |
|---|---|---|
| OCS Preservation | Experimental | OCS Preservation and Assessment Receives: Device: Preservation of Hearts for Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
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 posted23 Dec 2014 (estimated)
- Study start16 Sep 2015
- Primary completion25 Apr 2018
- Study completion2 Mar 2019
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.
- More trials run by TransMedicsThe sponsor's other registered studies.
- 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
- NCT02323321
- Sponsor's protocol ID
- OCS-CAR-012014
- Acronym
- EXPANDHeart
- Status last verified
- Aug 2019
- First submitted
- 18 Dec 2014
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
- ClinicalTrials.gov ID
- NCT02323321
- Acronym / sponsor ID
- EXPANDHeart / OCS-CAR-012014
- Conditions
- Heart Transplant
- Keywords
- heart transplant, heart preservation, beating heart transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation
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: Preservation of Hearts for TransplantationOCS Preservation and Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Registered male or female primary Heart transplant candidate
- Age ≥18 years old
Key exclusion criteria (3 listed)
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant
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 |
|---|---|---|
| Preservation of Hearts for TransplantationPreserving and Assessing Expanded Criteria Donor Hearts for Transplantation | Device | OCS Preservation |
Primary outcome
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
Time frame: 30 Days
A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
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.
Related trials for Heart Transplant
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservation of Hearts for Transplantation in people with Heart Transplant, run by TransMedics at 11 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 2 inclusion and 3 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 11 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 Transplant and Absence of Severe Primary Heart Graft Dysfunction 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 NCT02323321, 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.