This study is testing the safety and effectiveness of the CorMatrix Cor TRICUSPID ECM Valve. This device is designed to replace a diseased tricuspid valve, which is one of the heart's four valves. This includes tricuspid valve disease that might be related to heart problems present at birth (congenital heart disease). The study aims to see if the valve can be successfully implanted and if it works as intended. You may be able to join if you are between 1 and 85 years old, have a tricuspid valve that needs surgical treatment, and are willing to follow up with the study team. The main goal is to measure how successful the procedure is 30 days after surgery. The study is currently unclear about its recruitment status and plans to enroll up to 78 participants.

Study design

This is a multi-center, prospective, single-arm study, meaning all participants will receive the CorMatrix Cor TRICUSPID ECM Valve. The study plans to enroll up to 78 participants, including both adults and children.

What's involved

You would undergo surgery to replace your tricuspid valve with the CorMatrix Cor TRICUSPID ECM Valve. You would also need to comply with follow-up evaluations.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint, procedural success, is measured at 30 days after surgery.

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