This study is looking at the Occlutech Atrial Flow Regulator (AFR) device in patients who have a failing Fontan circulation (a type of heart surgery for complex heart defects). It's an observational study, meaning researchers are reviewing existing medical records from patients who have already received the AFR device through a special FDA program. The goal is to understand how safe and effective the Occlutech AFR is in real-life situations. Researchers will specifically look at how well the device works to maintain a shunt (a small opening) one year after it's placed. About 25 patients will be included in this study. You can join if you've already been treated with an AFR device for failing Fontan circulation under the FDA's Expanded Access Program.

Study design

This is an observational study that will look at existing medical data from about 25 patients. It is a single-arm study, meaning all participants received the same intervention.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The study will evaluate the device's effectiveness at 1 year after the procedure.

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