Autus Valve Pivotal Study is a research project to test a new heart valve in children aged 18 months to 16 years who need pulmonary valve replacement surgery. The pulmonary valve helps blood flow from the heart to the lungs. The study uses the Autus Size-Adjustable Valve, which can be resized before and after being placed in the body. This valve can grow with the child, which means fewer surgeries in the future. Children will be checked before getting the valve, right after, at hospital release, 30 days later, 6 months later, and then once a year for 10 years. If the valve is resized later, check-ups will continue for at least another year.

• The study lasts up to 10 years with regular check-ups.
• Participants must be willing to attend all follow-up visits.
• Consider risks like potential need for more surgeries or infection.

If you have questions or think you might qualify, talk to your doctor. They can help determine if this study is a good fit for you.