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

Heart Failure Clinical Trial

Official title:

Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06080074
• Other study ID #: 72467
• Secondary ID: 1R01FD007833-01A
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: September 30, 2027

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Christopher SD Almond, MD, MPH
• Phone: 6507237913
• Email: calmond[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 Product Development)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Cardiomyopathies
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• Shock, Cardiogenic

Intervention

Device:
• Cardiohelp device (VA-ECMO)
In children receiving the Cardiohelp device for severe heart failure, participants will be consented to a systematic data collection to describe the safety and effectiveness of the device in children.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Boston Children's Hospital, Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke-free survival to 30 days, recovery, ventricular assist device implant or transplant.	Survival in the absence of symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant	30 days
Primary	Symptomatic stroke	symptomatic stroke	30 days
Primary	Severe hemolysis	Severe hemolysis	30 days
Primary	Circuit change due to thrombus	ECMO circuit change due to thrombus	30 days
Primary	Major device malfunction	major device malfunction of the ECMO circuit	30 days
Primary	Renal failure	renal failure	30 days
Secondary	Incidence of all serious adverse events	Incidence rate of all serious adverse events (per day of support)	30 days