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
Single group
Ventrix Bio Extracellular Matrix
DrugVentriGel 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.
Number of ventricular tachycardia events
Number of sustained/symptomatic ventricular tachycardia incidences requiring intervention with inotropic support or anti-arrhythmics
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)
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)
Number of patients requiring new permanent pacemaker
Number of patients requiring new permanent pacemaker
Change in right ventricular ejection fraction
This will be measured by serial echocardiograms and MRI scans
Change in right ventricular end diastolic volume
This will be measured by serial echocardiograms and MRI scans
Change in right ventricular end systolic volume
This will be measured by serial echocardiograms and MRI scans
Change in tricuspid regurgitation
This will be measured by serial echocardiograms and MRI scans. tricuspid regurgitation measured by tricuspid valve vena contracta width
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Emory University
Lead sponsor
Ventrix, Inc.
Collaborator
University of California, San Diego
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
