The purpose of this study is to determine whether an experimental device called the Siegel Transcatheter Aortic Valve Replacement (TAVR) System is safe and effective in treating adults who have aortic stenosis, a condition in which the opening in the aortic valve is narrowed. Replacement of the valve is usually recommended when the stenosis is severe. Participants in this study are patients for whom a non-surgical procedure to replace the heart valve to treat aortic stenosis has been recommended. Participants will undergo the TAVR treatment procedure using the Siegel valve system, during which the doctor will make a small cut in the groin. A thin, flexible tube is inserted into the artery to guide the Siegel heart valve up into the heart. The valve is then expanded using a balloon to fit inside the diseased valve.
What is the full name of this clinical trial?
Siegel Transcatheter Aortic Valve EFS Study: Use of Siegel TAVR System in Subjects With Severe Aortic Stenosis