PARADIGM is a study to check if a special device, called the Amplatzer Valvular Plug III (AVP III), can safely and effectively fix leaks around heart valves. These leaks, known as paravalvular leaks (PVL), occur when there's a gap between the heart valve and the heart. The study focuses on patients who have had a mechanical or biological valve put in their heart's aortic or mitral position. It will take place in about 25 locations in the US, Europe, and Canada, involving 200 participants. Participants will go through the AVP III procedure and will be checked before and after the procedure at different times to see how they are doing. The checks will include heart images, blood tests, and questions about their health. Participants must be at least 18 years old and have a significant leak that can be fixed with the device.

• The study lasts for 1 year with follow-up visits.
• Participants will undergo a procedure for PVL closure.
• Some people may not be eligible due to health conditions.