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NCT02323321 Clinical Trial

International EXPAND Heart Pivotal Trial

Heart Transplant Clinical Trial

— EXPANDHeart  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02323321
Other study ID # OCS-CAR-012014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2015
Est. completion date March 2, 2019

Study information
Verified date August 2019
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date March 2, 2019
Est. primary completion date April 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Preservation of Hearts for Transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Massachusetts General Hospital Boston Massachusetts
United States Duke University Medical Center Durham North Carolina
United States Spectrum Health Grand Rapids Michigan
United States Indiana University Indianapolis Indiana
United States Cedars-Sinai Medical Center Los Angeles California
United States Minneapolis Heart Institute Minneapolis Minnesota
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mount Sinai New York New York
United States University of Washington Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 30 Days
See also
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