International EXPAND Heart Pivotal Trial

Completed · Not applicable

Conditions studied: Heart Transplant

In brief

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

Key facts

Study ID

NCT02323321

Run by

TransMedics

People needed

75

Starts

2015-09-16

Expected to finish

2019-03-02

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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