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Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)
Sponsor: Emory University
Summary
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
Key Details
Gender
All
Age Range
Any - 1 Year
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-08
Completion Date
2028-09
Last Updated
2025-03-10
Healthy Volunteers
No
Conditions
Interventions
Ventrix Bio Extracellular Matrix
VentriGel will be administered by injection into the right ventricle of the heart in the following defined doses per injection. There will be a total of 8 injections. The proposed dose of up to 0.6 mL is administered as up to 8 sequential injections of 4 injections of 0.1 mL each and 4 injections of 0.05 mL each.
Locations (1)
Children's Healthcare of Altanta
Atlanta, Georgia, United States