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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.
 
ClinicalTrials.gov Identifier: NCT02323321
Recruitment Status : Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
TransMedics

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)
Estimated Enrollment : 75 participants
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)
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02323321


Locations
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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
TransMedics

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT02323321     History of Changes
Other Study ID Numbers: OCS-CAR-012014
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by TransMedics:
heart transplant
heart preservation
beating heart transplant