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)
NCT Number: NCT06461676
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hypoplastic Left Heart Syndrome
Interventions: DRUG: Ventrix Bio Extracellular Matrix
Sponsor: Emory University
Collaborators: Ventrix, Inc.|University of California, San Diego
Sex: ALL
Age: CHILD
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-09-30
Locations: Children's Healthcare of Altanta, Atlanta, Georgia, 30322, United States

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

Primary Outcome Measures: Number of ventricular tachycardia events, Number of sustained/symptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics, upto 30 days post operation|Number of Cardiogenic shock events, Cardiogenic shock (i.e. tissue hypoperfusion presented by hypotension due to decreased cardiac output, determined by rising lactate levels (5x normal levels in first 24 hours, 2.5x normal levels in first 30 days), Day 1, 30 days post operation|Number of unplanned cardiovascular operation events, Unplanned cardiovascular operation due to right ventricular intramyocardial injection site bleeding in the first 5 days after Stage II operation decreased cardiac output, determined by rising lactate levels (5x normal levels in first 24 hours, 2.5x normal levels in first 30 days), 30 days post operation|Number of patients requiring new permanent pacemaker, Number of patients requiring new permanent pacemaker, upto 30 days post operation|Stroke or embolic event, Stroke or embolic event to the brain determined by CT scan, upto 30 days post operation|Number of Adverse Events, Number of adverse events occurring post op, upto 30 days post operation|Number of deaths, Number of deaths occurring post op, upto 30 days post operation|Number of VentriGel products manufactured and delivered to subjects, 12 months|Number of patients receiving Cardiac MRIs, Baseline, 6 months, 12 months
Secondary Outcome Measures: Change in right ventricular ejection fraction, This will be measured by serial echocardiograms and MRI scans, Baseline, 6 months, 12 months post operation|Change in right ventricular end diastolic volume, This will be measured by serial echocardiograms and MRI scans, Baseline, 6 months, 12 months post operation|Change in right ventricular end systolic volume, This will be measured by serial echocardiograms and MRI scans, Baseline, 6 months, 12 months post operation|Change in tricuspid regurgitation, This will be measured by serial echocardiograms and MRI scans. tricuspid regurgitation measured by tricuspid valve vena contracta width, Baseline, 6 months,12 months post operation|Change in right ventricular function Fractional Area Change, This will be measured by serial transthoracic echocardiogram (TTE), Baseline, 6 months,12 months post operation|Change in right ventricular global longitudinal strain, This will be measured by serial transthoracic echocardiogram (TTE), Baseline, 6 months,12 months post operation|Change in right ventricular global circumferential strain, This will be measured by serial transthoracic echocardiogram (TTE), Baseline, 6 months,12 months post operation|Change in right ventricular Tricuspid Annular Plane Systolic Excursion (TAPSE), This will be measured by serial transthoracic echocardiogram (TTE), Baseline, 6 months,12 months post operation|Change in right atrial volume indexed, This will be measured by serial transthoracic echocardiogram (TTE), Baseline, 6 months,12 months post operation