Precise Cooler for Donor Heart Transport

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07354763
Status
Not Yet Recruiting

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Conditions

  • Heart Transplantation

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Organ transport using SherpaPak — DEVICE
    Paragonix SherpaPak
  • Ryobi cooler for Organ Transport — DEVICE
    This is a temperature-controlled cooler without a gel or ice

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Jan 15, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Organ transport using Standard of Care Paragonix SherpaPak
    In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
  • Experimental: Organ transport using the RYOBI cooler.
    In this arm, the organ will be transported using the Ryobi cooler

Primary Outcome Measure

Incidence of primary graft dysfunction [ Time Frame: From Randomization to 30 days after heart transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Co-Investigator Cardiothoracic Surgeon
[email protected]
310-423-3300

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CA

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