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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 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.

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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

Conditions Studied

Heart Transplant

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

FieldValue
Enrollment Target 75 participants
Start Date 2015-09-16
Est. Completion 2019-03-02
Phase NA

Sponsor

TransMedics

23 total trials

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What the Registry Record Tells You About NCT02323321

The ClinicalTrials.gov registry entry for NCT02323321 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The listed sponsor is TransMedics, which has 23 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.