Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
NCT06080074
This study is recruiting at 5 US sites in 5 states, according to its ClinicalTrials.gov record last updated .
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: 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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Heart Failure
- Cardiogenic Shock
- Congenital Heart Disease
- Cardiomyopathies
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Stanford University
- Last updated on ClinicalTrials.gov
- August 10, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Lucile Packard Children's Hospital · Palo Alto, CA
New York · 1
- Cuimc/Nyph · New York, NY
North Carolina · 1
- Duke University Hospital · Durham, NC
Texas · 1
- Children's Health Dallas · Dallas, TX
Washington · 1
- Seattle Children's Hospital · Seattle, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.