Clinical Trial TitleTo establish the safety and effectiveness of transcatheter heart valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Clinical Trial Protocol Description:
The study is designed for patients with asymptomatic, severe, calcific aortic stenosis. The object of the study is to determine safety and effectiveness of transcatheter heart valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcified aortic stenosis. Subjects will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) or conservative medical management. Currently 75 active sites have been enrolling and nationwide, 1109 patients will be recruited for this study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 65 years of age or older.
- Have a diagnosis of severe, calcified aortic stenosis.
- Are asymptomatic by physician assessment and negative treadmill test.
- Have LV ejection fraction ≥50%.
You will be excluded from the study if any of the following criteria apply to you:
- Have symptoms for aortic stenosis.
- Have any concomitant valvular, aortic, coronary artery disease requiring surgery.
- Are currently participating in an investigational drug or another device study.
This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided.