What we are studying
The purpose of this research study is to obtain data on the safety and effectiveness of the CoreValve System and Evolut R System on patients considered low risk for SAVR.
The Corevalve System and Evolut R System have been approved by the US Food and Drug Administration (FDA) for patients considered to be extreme or high risk for open heart surgery, but it has not been approved for patients considered to be low risk for open heart surgery. Therefore, the CoreValve System and Evolut R System are considered “investigational devices” in this low risk patient population. This means that research studies are required to determine if they are safe, and provide clinical benefit. Data from this study will be used to support regulatory submissions to obtain commercial approval for the CoreValve System and Evolut R System in low risk patients.
Compensation for time and travel for follow-up visits.