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Treatment Study for Patients with Asymptomatic Severe Aortic Stenosis
The purpose of this study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific aortic stenosis and do not have symptoms. Standard of care is to wait to perform a valve replacement procedure until symptoms occur. Study subjects that participate in this study will be chosen at random (selected by chance, like the flip of a coin) to be in one of two groups that are part of the main study, TAVR Group or Clinical Surveillance Group. The main goals are to successfully place the aortic valve device, relieving or possibly eliminating the narrowing in the valve, while avoiding complications.
In order to participate you must meet the following criteria:
- Are 65 years of age or older and have aortic valve stenosis.
- Are asymptomatic from aortic valve stenosis.
- Are considered low risk for surgery, as patients will be randomized to either transcatheter aortic valve replacement (TAVR) or Clinical Surveillance Arm (CSA).
- Agree to comply with all required post-procedure follow-up visits including annual visits through ten years and analysis close date visits.
You will be excluded from the study if any of the following criteria apply to you:
- Have chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy.
- Have severely reduced kidney function.
- Are currently participating in an investigational drug or another device study.
This is a partial list of elgibility requirements.