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

Stanford University

Status: Invitation-only

Conditions: Congenital Heart Disease; Heart Failure; Cardiomyopathies; Cardiogenic Shock

Treatments: Device: Cardiohelp device (VA-ECMO)

Study type: Interventional

Funder types: Other

Identifiers

NCT06080074

1R01FD007833-01A1

72467

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

participants receiving the Cardiohelp device according to a standardized management guideline

Experimental group

Description:

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.

Treatment:

Device: Cardiohelp device (VA-ECMO)