This study is testing a new device called the MASA Valve. It's designed to help children and young adults (up to 22 years old) who have certain heart conditions like Tetralogy of Fallot or Pulmonary Stenosis. The MASA Valve replaces a faulty pulmonary valve or a previously implanted device, helping blood flow correctly from the heart to the lungs. The main goal of this early study is to see if the MASA Valve is safe and works as intended, specifically looking at whether patients avoid device-related death, needing the device removed, or needing another surgery related to the device, all within one year. We are looking for about 10 participants for this study.

Study design

This is an interventional study, meaning participants will receive the MASA Valve. It aims to enroll about 10 participants.

What's involved

You would undergo surgery to replace your pulmonary valve with the MASA Valve. You would also need to return for follow-up appointments for one year after the surgery.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for one year after the surgery to assess the device's safety and effectiveness.

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