NCT07354763

Precise Cooler for Donor Heart Transport

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Heart Transplantation

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-15
• Completion: 2027-12-01
• First posted: 2026-01-21
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study