Clinical Research Studies

The purpose of the trial is to evaluate the use of a device to treat patients with Heart Failure (HF) who have moderate aortic stenosis. Moderate aortic stenosis does not need treatment in patients with normal hearts. This study is testing the possibility that TAVR using the Sapien 3 valve may be beneficial in patients with moderate aortic stenosis and heart failure. The device used in this study is the Edwards SAPIEN 3 transcatheter heart valve system. It has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis. However, in this study the device is considered investigational because patients who participate will have moderate aortic stenosis with heart failure. The research will compare 2 groups of patients: those that will get the heart valve with optimal heart failure therapy to those that only get optimal heart failure therapy. Optimal heart failure therapy is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.