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International EXPAND Heart Pivotal Trial (EXPANDHeart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02323321
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 21, 2020
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Heart Transplant Device: Preservation of Hearts for Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 16, 2015
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02323321

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90211
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
United States, New York
Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
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Responsible Party: TransMedics Identifier: NCT02323321    
Other Study ID Numbers: OCS-CAR-012014
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: August 2019
Keywords provided by TransMedics:
heart transplant
heart preservation
beating heart transplant