The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS).
The main questions it aims to answer are:
* Whether VentriGel is safe in treating patients with HLHS * Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection
Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age
Subjects undergoing the Stage II Glenn operations who do not have HLHS
Subjects requiring mechanical circulatory support within 5 days pre pre-surgical intervention
Parent or guardian unwilling or unable to comply with necessary follow-up(s)
Immunosuppressive diseases or subjects who require treatment with interventions that cause immunosuppression
Emory University
Lead sponsor
Ventrix, Inc.
Collaborator
University of California, San Diego
Collaborator