Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Not Applicable

• Conditions: Heart Failure; Cardiogenic Shock; Congenital Heart Disease; Cardiomyopathies
• Interventions: Device: Cardiohelp device (VA-ECMO)

• Registration Number: NCT06080074
• Lead Sponsor: Stanford University

Brief Summary

The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question\[s\] it aims to answer are:

* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?

* What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children?

Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. 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.

Outcomes will be compared to performance goals (PG) derived from the ECMO literature.

Funding Source -- FDA OOPD (Office of Orphan Products Development)

Detailed Description

This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure. Despite more than 50 years of use and significant mortality, no standalone ECMO device has ever been FDA-cleared for ECMO. All ECMO use in children is off-label and this may explain why there is significant center-based variation in ECMO use that is not evidence driven. This study seeks to change that by collecting systematic safety and effectiveness data on a single standardized ECMO circuit (Cardiohelp Device). The goal is to provide the data necessary to secure FDA clearance of the first pediatric ECMO system, to determine the optimal performance range of the Cardiohelp device in infants and children, and to provide the FDA with a predicate device to support FDA clearance of other ECMO systems.

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Status Verified: 2025-04
• Study Start: 2025-04-15
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 0 to 16 years of age
2. Body weight 3 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during any hospitalization
5. Written informed consent from the parent or legally authorized representative.

Exclusion Criteria

Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:

1. Gestational Age <37 weeks
2. Bleeding or coagulopathy that is a contraindication to anticoagulation
3. Irreversible renal, hepatic or lung failure
4. Stroke or uncertain neurological status within the past 30 days
5. Severely malnourished
6. Use of an ECMO system other than the Cardiohelp
7. VV-ECMO or ECMO for primary respiratory failure
8. Goals of patient to focus on comfort measures only.
9. Failure to separate from cardiopulmonary bypass

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
participants receiving the Cardiohelp device according to a standardized management guideline	Cardiohelp device (VA-ECMO)	participants receiving the Cardiohelp device for severe heart failure will be managed according to a standardized treatment guideline to estimate the safety and effectiveness of the device for up to 30 days of support.

Primary Outcome Measures

Name	Time	Method
Major device malfunction	30 days	major device malfunction of the ECMO circuit
Stroke-free survival to 30 days, recovery, ventricular assist device implant or transplant.	30 days	Survival in the absence of symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant
Severe hemolysis	30 days	Severe hemolysis
Renal failure	30 days	renal failure
Circuit change due to thrombus	30 days	ECMO circuit change due to thrombus
Symptomatic stroke	30 days	symptomatic stroke

Secondary Outcome Measures

Name	Time	Method
Incidence of all serious adverse events	30 days	Incidence rate of all serious adverse events (per day of support)

Trial Locations

Locations (5)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Children's Health Dallas; 🇺🇸 Dallas, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Cuimc/Nyph; 🇺🇸 New York, New York, United States