Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

International EXPAND Heart Pivotal Trial

NCT02323321 · View on ClinicalTrials.gov ↗

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

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

16 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02323321

The ClinicalTrials.gov registry entry for NCT02323321 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TransMedics, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02323321 reports 11 study locations spanning 9 distinct geographic areas — top geographies include Michigan, Minnesota, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02323321?

The interventions under investigation include: Preservation of Hearts for Transplantation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02323321?

This trial is sponsored by TransMedics, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial