Precise Cooler for Donor Heart Transport

NCT07354763 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00004185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Transplantation

Keywords

Donor heart; Heart transplantation; organ procurement; heart failure

Outcome Measures

Primary Outcomes (1)

• 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.

  From Randomization to 30 days after heart transplantation

Study Arms (2)

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

Device: Organ transport using SherpaPak

Organ transport using the RYOBI cooler.

EXPERIMENTAL

In this arm, the organ will be transported using the Ryobi cooler

Device: Ryobi cooler for Organ Transport

Interventions

Organ transport using SherpaPak DEVICE

Paragonix SherpaPak

Organ transport using Standard of Care Paragonix SherpaPak

Ryobi cooler for Organ Transport DEVICE

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

Organ transport using the RYOBI cooler.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Dominic Emerson, MD

CONTACT

310-423-3300; dominic.emerson@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgical Director of Heart Transplant and Mechanical Circulatory Support, Director of Robotic Cardiac Surgery, and Director of the Accreditation Council for Graduate Medical Education Fellowship Program

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)