The CoreValve System and Evolut R have both been approved by the Food and Drug Administration (FDA) for use in patients who are at high and extreme risk for surgical aortic valve replacement (SAVR). This means that CoreValve and Evolut R are commercially available for use in patients who are deemed high or extreme risk for SAVR by their doctor. However, CoreValve and Evolut R have not been approved by the FDA for use in patients who are at low risk for SAVR. Therefore, the CoreValve System and Evolut R System are considered "investigational devices" in this low risk patient population and research studies are required to determine if they are safe, and provide clinical benefit.
The randomized phase of the trial (above) has concluded, and a new phase has been initiated, which is called single arm (non-randomized). In this phase, all patients will receive a study device. The study doctor will schedule 4 visits with that include a baseline/pre-implant, implant, 1 month, and 12 month visit. Information about the participant will continue to be collected for 10 years after the implant procedure.
The devices being used in this study are considered investigational because they have not been approved by the U.S. Food and Drug Administration (FDA) for patients like you who are at low risk for major complications from open heart surgery to replace the aortic valve. The study devices have, however, been approved by the FDA for use in patients who are at intermediate, high, and extreme risk for SAVR. This means that they are commercially available for use in patients who are deemed intermediate, high or extreme risk for SAVR by their doctor. Although the study devices are considered investigational in the patient population being studied, none of the procedures in this research study are experimental, including the implant itself.