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Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
NCT06080074 · View on ClinicalTrials.gov ↗
Study Summary
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children. 2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial The main questions the Cardiohelp single-arm trial seeks to answer are: * What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? * Should the Cardiohelp device be FDA-cleared for children based on the results of the study? * What are the optimal performance specifications of the Cardiohelp device in children? The main questions the blood thinner randomized trial seeks to answer are: * Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device? * How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications. For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount
Conditions Studied
Interventions
- DEVICE Cardiohelp device (VA-ECMO)
- DRUG Heparin
- DRUG Bivalirudin
Study Locations (5)
California
- Lucile Packard Children's Hospital — Palo Alto
New York
- Cuimc/Nyph — New York
North Carolina
- Duke University Hospital — Durham
Texas
- Children's Health Dallas — Dallas
Washington
- Seattle Children's Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2029-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06080074
The ClinicalTrials.gov registry entry for NCT06080074 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Heart Failure appearing as the primary indexed condition, and to 3 interventions — of which Cardiohelp device (VA-ECMO) 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: NCT06080074 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, New York, North Carolina. 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 NCT06080074 about?
NCT06080074 is a clinical study titled "Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System". There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of sup...
What is the current status of trial NCT06080074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2025-04-15. Estimated completion is 2029-09.
What conditions does trial NCT06080074 study?
This clinical trial studies the following conditions: Heart Failure, Congenital Heart Disease, Cardiomyopathies, Cardiogenic Shock. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06080074?
The interventions under investigation include: Cardiohelp device (VA-ECMO) (DEVICE), Heparin (DRUG), Bivalirudin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06080074?
This trial is sponsored by Stanford University, which has 1,643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06080074 being conducted?
This trial has 5 study locations across California, New York, North Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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