PARADIGM is a study to test a device called the Amplatzer Valvular Plug III (AVP III). This plug is used to fix a problem called paravalvular leak (PVL), which sometimes happens after getting a new heart valve. The heart valves can be mechanical (made of metal and plastic) or biological (made from animal tissue). The study will take place in about 25 places in the US, Europe, and Canada, with 200 people participating. These participants will have the AVP III placed to close their PVL. Doctors will check on participants' health through various tests and questions about their symptoms and quality of life. They will do this at different times: before the procedure, at discharge, 30 days, 6 months, and 1 year after the procedure.
- Study involves visits over one year.
- Participants must have a specific heart valve condition.
- Informed consent is required to join.
People with certain health issues or conditions that might interfere with the study cannot join. The study ensures safety and looks for any unwanted effects. Participation is voluntary, and all participants must be 18 years or older.