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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: Recruiting Phase 2 study of Heart Failure and Congenital Heart Disease, sponsored by Stanford University.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Survival in the absence of severe symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant. For patients with stroke definitely or probably related to ECMO, symptoms and severity will be determined at hospital discharge or 90 days, whichever is first.
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 |
What NCT06080074 shows while recruiting
NCT06080074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower).
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 lists 5 locations in 5 states (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.
Where NCT06080074's enrollment target sits among peer trials
50 281st of 397 higher than 106 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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