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)

Inclusion Criteria: * Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age Exclusion Criteria: * 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 * A history of tumor or malignancy * Coagulation disorders * Chromosomal abnormalities that limit expected survival to \< 1 year * Abnormal lab values that may increase the risk of the study procedure (WBC \>20,000 cells/ul or \< 1,000 cells/ul; platelet count \< 50,000 cells/ul; Hgb \< 8.0 gm/dl; LFTs \> 2x reference lab upper limit of normal) at the time of screening * Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks * Ventricular arrhythmias due to antiarrhythmic pharmacological therapy