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Completed Not applicable Interventional Results available

International EXPAND Heart Pivotal Trial

ClinicalTrials.gov ID: NCT02323321

Public ClinicalTrials.gov record NCT02323321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 11:21 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02323321
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
TransMedics
Industry
Enrollment
75 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 16, 2015 (Actual)
Primary completion
Apr 25, 2018 (Actual)
Completion
Mar 2, 2019 (Actual)
Last update posted
Jan 17, 2025

2015 – 2019

United States locations

U.S. sites
11
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90211 —
Indiana University Indianapolis Indiana 46202 —
Massachusetts General Hospital Boston Massachusetts — —
University of Michigan Ann Arbor Michigan — —
Spectrum Health Grand Rapids Michigan — —
Minneapolis Heart Institute Minneapolis Minnesota 55407 —
University of Minnesota Medical Center Minneapolis Minnesota — —
Mount Sinai New York New York 10029 —
Duke University Medical Center Durham North Carolina — —
Vanderbilt University Medical Center Nashville Tennessee — —
University of Washington Medical Center Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02323321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 17, 2025 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02323321 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →