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Donors After Circulatory Death Heart Trial
NCT03831048 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Conditions Studied
Interventions
- DEVICE OCS Heart System
- OTHER Cold Storage
Study Locations (20)
California
- University of California San Diago — La Jolla
- Cedars Sinai — Los Angeles
- Stanford University — Palo Alto
Florida
- Mayo Clinic Florida — Jacksonville
- AdventHealth — Orlando
- Tampa General Hospital — Tampa
Massachusetts
- Tufts Medical Center — Boston
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
New York
- Nyph/Cumc — New York
- Montefiore — The Bronx
- Westchester Medical Center — Valhalla
Minnesota
- Minneapolis Heart Institute — Minneapolis
- University of Minnesota — Minneapolis
Connecticut
- Yale New Haven Hospital — New Haven
Georgia
- Emory University Hospital — Atlanta
Illinois
- Northwestern Medicine — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2021-09-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03831048
The ClinicalTrials.gov registry entry for NCT03831048 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 180 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 2 interventions — of which OCS Heart System 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: NCT03831048 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Massachusetts. 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 NCT03831048 about?
NCT03831048 is a clinical study titled "Donors After Circulatory Death Heart Trial". To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
What is the current status of trial NCT03831048?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2019-11-26. Estimated completion is 2021-09-28.
What conditions does trial NCT03831048 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 NCT03831048?
The interventions under investigation include: OCS Heart System (DEVICE), Cold Storage (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03831048?
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 NCT03831048 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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