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)

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Hypoplastic Left Heart Syndrome
Interventions
DRUG

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.

Trial Locations (1)

30322

Children's Healthcare of Altanta, Atlanta

All Listed Sponsors
collaborator

Ventrix, Inc.

INDUSTRY

collaborator

University of California, San Diego

OTHER

lead

Emory University

OTHER