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

NCT ID: NCT06080074

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Heart Failure Cardiogenic Shock Congenital Heart Disease Cardiomyopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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participants receiving the Cardiohelp device according to a standardized management guideline

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.

Group Type EXPERIMENTAL

Cardiohelp device (VA-ECMO)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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 the current hospitalization

Exclusion Criteria

1. Gestationally-corrected 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
10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.
11. Patients who are pregnant or breastfeeding.
12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)
Minimum Eligible Age

0 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Almond

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynn Sleeper, ScD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Caroline Ozment, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Lucile Packard Children's Hospital

Palo Alto, California, United States

Site Status

Cuimc/Nyph

New York, New York, United States

Site Status

Duke University Hospital

Durham, North Carolina, United States

Site Status

Children's Health Dallas

Dallas, Texas, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1R01FD007833-01A1

Identifier Type: FDA

Identifier Source: secondary_id

View Link

72467

Identifier Type: -

Identifier Source: org_study_id