The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.
This study is seeking subjects who have been diagnosed with and may be receiving medical treatment for mitral valve disease. The purpose of this registry is to collect data to better understand the progression of mitral valve disease and the effects of different treatments on the disease and patient health. If you agree to participate in this registry, your medical data will be collected including your medical history, certain background information, and certain test images/results. This registry will also collect information about current and future treatments for your mitral valve disease and data from future disease-related follow-up visits. Data will be collected for up to 24 months. There are no additional visits or any additional testing required for this registry.