This study is testing a new type of blood vessel, called a Tissue Engineered Vascular Graft, for children with certain complex heart conditions like Hypoplastic Left Heart Syndrome (HLHS). These grafts are used in a surgery called an extracardiac total cavopulmonary connection (EC TCPC). Researchers want to see how safe and effective these grafts are over two years. They will be looking for any problems like narrowing (stenosis), widening (aneurysm), blood clots, or infections related to the graft. You might be able to join if you need an EC TCPC and meet other study requirements. The study aims to enroll 24 participants, but its current status is unclear.

Study design

This is a single-arm, open-label study, meaning all 24 participants will receive the Tissue Engineered Vascular Grafts. It is evaluating the safety and effectiveness of these grafts.

What's involved

You would undergo an EC TCPC surgery with the graft and have regular follow-up visits at Nationwide Children's Hospital for at least two years. These visits will include imaging tests like echocardiograms and MRIs.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for a minimum of two years after the graft is implanted to assess safety and tolerability.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.