International EXPAND Heart Pivotal Trial
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.
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)
Study identification
- NCT ID
- NCT02323321
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- TransMedics
- Industry
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Interventions
- Preservation of Hearts for Transplantation Device
Device
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 15, 2015
- Primary completion
- Apr 24, 2018
- Completion
- Mar 1, 2019
- Last update posted
- Jan 16, 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 16, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02323321 live on ClinicalTrials.gov.