NCT06080074View on ClinicalTrials.gov

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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Heart FailureCardiogenic ShockCongenital Heart DiseaseCardiomyopathies
Interventions
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.

Trial Locations (5)

10032

Cuimc/Nyph, New York

27710

Duke University Hospital, Durham

94304

Lucile Packard Children's Hospital, Palo Alto

95235

Children's Health Dallas, Dallas

98105

Seattle Children's Hospital, Seattle

Sponsors

Collaborators (1)

Duke University
All Listed Sponsors
collaborator

Boston Children's Hospital

OTHER

collaborator

Duke University

OTHER

lead

Stanford University

OTHER

NCT06080074 - Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System | Biotech Hunter | Biotech Hunter