Mitral valve disease affects the heart's mitral valve, which helps blood flow through the heart. This study is testing a new way to treat this disease using the Cephea Mitral Valve System. This is for patients who have symptoms and need treatment but are not suitable for open-heart surgery. Instead, a transcatheter therapy, which is a less invasive procedure using a tube, is used. The main goal is to see if this new treatment is safe and works well. Patients with mitral regurgitation (when the valve leaks, causing blood to flow backward) or mitral stenosis (when the valve is too tight) may be eligible. However, those who had previous heart procedures that could affect the new valve or need emergency surgery cannot join. The study is still in early stages, so it's important to understand the potential risks and benefits.
- The study examines safety and effectiveness of a new valve system.
- Patients must have mitral valve disease and be unsuitable for open-heart surgery.
- Previous heart surgeries may exclude participation.