Heart TransplantationNCT07354763
Precise Cooler for Donor Heart Transport
A study testing Organ transport using SherpaPak and Ryobi cooler for Organ Transport in people with Heart Transplantation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Organ transport using SherpaPak and Ryobi cooler for Organ Transport
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Individuals 18 years old or older are included.
- Individuals undergoing isolated heart transplantation are included.
Who cannot join
- Any records flagged "break the glass" or "research opt out."
- Any patients undergoing multi-organ transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
Co-Investigator Cardiothoracic Surgeon, 310-423-3300, Laura.DiChiacchio@cshs.org
About this study
Official title: Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
The investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.
Read the detailed description
The purpose of this study is to compare outcomes following heart transplant using two different storage devices for transport of the donor heart, an adjustable temperature cooler or a commercially available storage device called the Paragonix SherpaPak.
When a donor heart is identified for transplant, the method of storage during transportation will be randomized to one of two different options for cold storage. All other parts of the participant's care will then continue per usual standard of care. In the thirty days following transplant, the research team will review the participant's medical record to see what medications were used after transplant, what diagnostic studies like echocardiograms showed, and to collect basic information about the participant's medical history.
- Conditions
- Heart Transplantation
- Being tested
- Organ transport using SherpaPak, Ryobi cooler for Organ Transport
- Keywords
- Donor heart, Heart transplantation, organ procurement, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ transport using SherpaPakDevice
Paragonix SherpaPak
Ryobi cooler for Organ TransportDevice
This is a temperature-controlled cooler without a gel or ice
| Study group | Role | What they receive |
|---|---|---|
| Organ transport using Standard of Care Paragonix SherpaPak | Active comparator | In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix Receives: Device: Organ transport using SherpaPak |
| Organ transport using the RYOBI cooler. | Experimental | In this arm, the organ will be transported using the Ryobi cooler Receives: Device: Ryobi cooler for Organ Transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of primary graft dysfunction
compare the incidence of primary graft dysfunction between patients randomized to donor heart preservation using the adjustable temperature RYOBI cooler (Model # Pi1824QBT) (n = 40) versus the Paragonix SherpaPak (n = 40) in cases where the anticipated total ischemic time for the graft is between 120 and 240 minutes.
Measured: From Randomization to 30 days after heart transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has two study groups. Organ transport using the RYOBI cooler and Organ transport using the Paragonix SherpaPak This means that you will be put in a study group by chance (like flipping a coin). You will be randomly put in one of the above study groups. You will have an equal chance of being placed in any one of the groups described above. A computer will randomly put you in a study group. We do this because no one knows if the results in one study group.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominic Emerson, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354763
- Sponsor's protocol ID
- STUDY00004185
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
- ClinicalTrials.gov ID
- NCT07354763
- Acronym / sponsor ID
- STUDY00004185
- Conditions
- Heart Transplantation
- Keywords
- Donor heart, Heart transplantation, organ procurement, heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (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 investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.
Detailed description
The purpose of this study is to compare outcomes following heart transplant using two different storage devices for transport of the donor heart, an adjustable temperature cooler or a commercially available storage device called the Paragonix SherpaPak.
When a donor heart is identified for transplant, the method of storage during transportation will be randomized to one of two different options for cold storage. All other parts of the participant's care will then continue per usual standard of care. In the thirty days following transplant, the research team will review the participant's medical record to see what medications were used after transplant, what diagnostic studies like echocardiograms showed, and to collect basic information about the participant's medical history.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study has two study groups. Organ transport using the RYOBI cooler and Organ transport using the Paragonix SherpaPak This means that you will be put in a study group by chance (like flipping a coin). You will be randomly put in one of the above study groups. You will have an equal chance of being placed in any one of the groups described above. A computer will randomly put you in a study group. We do this because no one knows if the results in one study group.
| Arm | Type | Receives |
|---|---|---|
| Organ transport using Standard of Care Paragonix SherpaPak | Active comparator | Device: Organ transport using SherpaPakIn this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix |
| Organ transport using the RYOBI cooler. | Experimental | Device: Ryobi cooler for Organ TransportIn this arm, the organ will be transported using the Ryobi cooler |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals 18 years old or older are included.
- Individuals undergoing isolated heart transplantation are included.
Key exclusion criteria (2 listed)
- Any records flagged "break the glass" or "research opt out."
- Any patients undergoing multi-organ transplantation.
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 |
|---|---|---|
| Organ transport using SherpaPakParagonix SherpaPak | Device | Organ transport using Standard of Care Paragonix SherpaPak |
| Ryobi cooler for Organ TransportThis is a temperature-controlled cooler without a gel or ice | Device | Organ transport using the RYOBI cooler. |
Primary outcome
Incidence of primary graft dysfunction
Time frame: From Randomization to 30 days after heart transplantation
compare the incidence of primary graft dysfunction between patients randomized to donor heart preservation using the adjustable temperature RYOBI cooler (Model # Pi1824QBT) (n = 40) versus the Paragonix SherpaPak (n = 40) in cases where the anticipated total ischemic time for the graft is between 120 and 240 minutes.
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organ transport using SherpaPak and Ryobi cooler for Organ Transport in people with Heart Transplantation, run by Cedars-Sinai Medical Center at 1 site 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 2 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Dominic Emerson, MD (310-423-3300, dominic.emerson@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary graft dysfunction (time frame: From Randomization to 30 days after heart transplantation). 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 18 Mar 2026.