International EXPAND Heart Pivotal Trial (EXPANDHeart)

April 11, 2022 updated by: TransMedics

International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)

To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90211
        • Cedars-Sinai Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
      • Grand Rapids, Michigan, United States
        • Spectrum Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
      • Minneapolis, Minnesota, United States
        • University of Minnesota Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registered male or female primary Heart transplant candidate
  • Age ≥18 years old

Exclusion Criteria:

  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
  • Multi-organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCS Preservation
OCS Preservation and Assessment
Device: Preservation of Hearts for Transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite endpoint of patient survival at Day-30 post transplant and absence of severe primary heart graft dysfunction in the first 24 hours post-transplantation
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransMedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Actual)

April 25, 2018

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OCS-CAR-012014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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