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NCT02323321 · ClinicalTrials.gov registry record · NA
International EXPAND Heart Pivotal Trial
A NA study of Heart Transplant, sponsored by TransMedics.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 11
- Study locations
NCT02323321: Completed NA study of Heart Transplant, sponsored by TransMedics.
NCT02323321 is a NA study of Heart Transplant that has completed, run by TransMedics. The registered enrollment target is 75 participants, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323321, a NA study of Heart Transplant, has completed, sponsored by TransMedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 11
- Study locations
Study 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
Primary Outcome
A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
Conditions Studied
Interventions
- DEVICE Preservation of Hearts for Transplantation
Study Locations (11)
Michigan
- University of Michigan - Ann Arbor
- Spectrum Health - Grand Rapids
Minnesota
- Minneapolis Heart Institute - Minneapolis
- University of Minnesota Medical Center - Minneapolis
California
- Cedars-Sinai Medical Center - Los Angeles
Indiana
- Indiana University - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Mount Sinai - New York
North Carolina
- Duke University Medical Center - Durham
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2015-09-16 |
| Est. Completion | 2019-03-02 |
| Phase | NA |
What the finished NCT02323321 record still lists
NCT02323321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 1 intervention - of which Preservation of Hearts for Transplantation is the first listed.
NCT02323321 lists 11 locations in 9 states (Michigan, Minnesota, California).
Frequently Asked Questions
What is clinical trial NCT02323321 about?
NCT02323321 is a clinical study titled "International EXPAND Heart Pivotal Trial". 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
What is the current status of trial NCT02323321?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2015-09-16. Estimated completion is 2019-03-02.
What conditions does trial NCT02323321 study?
This clinical trial studies the following conditions: Heart Transplant.
What interventions are being tested in trial NCT02323321?
The interventions under investigation include: Preservation of Hearts for Transplantation (DEVICE).
Who is sponsoring clinical trial NCT02323321?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02323321 being conducted?
This trial has 11 study locations across California, Indiana, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Transplant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02323321's enrollment target sits among peer trials
75 9th of 12 higher than 3 of 12 other Heart Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Transplant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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