Clinical trial NCT06080074: Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Cardiogenic Shock
Congenital Heart Disease
Cardiomyopathies
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Duke University
First posted: 2023-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants going on ECMO with the Cardiohelp Device for clinical reasons will managed /treated according to a standardized protocol (anticoagulation, circuit change, weaning guidelines, adverse event identification) to estimate the safety and effectiveness of the device.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Stroke-free survival to 30 days, recovery, ventricular assist device implant or transplant.
timeFrame: 30 days
measure: Symptomatic stroke
timeFrame: 30 days
measure: Severe hemolysis
timeFrame: 30 days
measure: Circuit change due to thrombus
timeFrame: 30 days
measure: Major device malfunction
timeFrame: 30 days
measure: Renal failure
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of all serious adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: New York
country: United States
facility: Cuimc/Nyph
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Dallas
country: United States
facility: Children's Health Dallas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Boston Children's Hospital
name: Lynn Sleeper, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Caroline Ozment, MD
role: PRINCIPAL_INVESTIGATOR
References: