Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06080074 · ClinicalTrials.gov registry record · Phase 2
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
A Phase 2 study of Heart Failure and Congenital Heart Disease, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT06080074 is a Phase 2 study of Heart Failure and Congenital Heart Disease that is actively recruiting participants, run by Stanford University. The registered enrollment target is 50 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06080074, a Phase 2 study of Heart Failure and Congenital Heart Disease, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
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.
NCT06080074 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, New York, North Carolina.
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.
What interventions are being tested in trial NCT06080074?
The interventions under investigation include: Cardiohelp device (VA-ECMO) (DEVICE), Heparin (DRUG), Bivalirudin (DRUG).
Who is sponsoring clinical trial NCT06080074?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
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.
-
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
RECRUITING · Phase 2
-
Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
RECRUITING · Phase 2
-
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
RECRUITING · Phase 2
-
Metformin for Pulmonary Hypertension HFpEF
RECRUITING · Phase 2
-
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
RECRUITING · Phase 2
-
Ertugliflozin in Chronic Heart Failure
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.