The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

This study is looking for people who have a significant leak in their pulmonary valve, meaning blood is flowing backward into their heart. Doctors will check this using special scans like an echo or an MRI. You would also need to be someone for whom doctors would normally consider surgery to repair or replace a heart valve or tube in the same area of the heart. Lastly, you must be willing to agree to participate in the study if you meet the other requirements.

However, some people would not be able to join. This includes individuals who have already had an operation to put in a special tube or a different man-made valve in a specific part of their heart (called the RV-PA conduit). Also, if the shape or structure of your heart in that area isn't suitable for the Harmony TPV device to be safely put in, you wouldn't be able to take part. For women, a positive pregnancy test would also mean you couldn't join. Finally, if doctors believe you have less than a year to live due to other serious health issues, you would not be eligible.

This study is mainly about following up with people who have already had the Harmony TPV device fitted. If you are part of this study, you will have regular check-ups and tests, typically involving visits to the hospital, to see how the valve is working and how you are feeling. These visits will likely include heart scans like echocardiograms or MRI scans. The aim is to follow people for a long time, extending up to ten years for some participants, to understand the long-term effects of the valve. There are no new medications being given as part of this follow-up study, as it focuses on the already implanted valve. The exact number of visits will depend on how long you have been in the study, but each visit helps doctors gather important information about the Harmony TPV.