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NCT Number: NCT07354763

Precise Cooler for Donor Heart Transport

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.

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Key information

Conditions

Heart Transplantation Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location contact

Co-Investigator Cardiothoracic Surgeon

CONTACT

[email protected]

310-423-3300

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals 18 years old or older are included.
  • Individuals undergoing isolated heart transplantation are included.

Exclusion criteria

  • Any records flagged "break the glass" or "research opt out."
  • Any patients undergoing multi-organ transplantation.

Treatment and study plan

Organ transport using SherpaPak

Device

Paragonix SherpaPak

Ryobi cooler for Organ Transport

Device

This is a temperature-controlled cooler without a gel or ice

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Emerson, MD

CONTACT

[email protected]

310-423-3300

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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