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
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of ventricular tachycardia events
Timeframe: upto 30 days post operation
Number of Cardiogenic shock events
Timeframe: Day 1, 30 days post operation
Number of unplanned cardiovascular operation events
Timeframe: 30 days post operation
Number of patients requiring new permanent pacemaker
Timeframe: upto 30 days post operation
Stroke or embolic event
Timeframe: upto 30 days post operation
Number of Adverse Events
Timeframe: upto 30 days post operation
Number of deaths
Timeframe: upto 30 days post operation
Number of VentriGel products manufactured and delivered to subjects
Timeframe: 12 months
Number of patients receiving Cardiac MRIs
Timeframe: Baseline, 6 months, 12 months