This study is looking for participants with severe aortic stenosis (narrowing of the aortic valve resulting in the obstructed passage of blood) who are considered high risk candidates for conventional (standard) open-heart surgery.

The purpose of this study is to evaluate the safety and effectiveness of the Edwards SAPIEN™ Transcatheter Heart Valve (THV).  The THV is intended to treat patients who are at high operative risk for traditional aortic valve replacement (AVR) surgery.  The standard medical treatments generally available to non-surgical patients with aortic stenosis may temporarily alleviate symptoms, but will not cure aortic stenosis permanently.  The THV is an investigational device, which means the valve is being studied and not for sale commercially.  Data is being collected on the valve for approval by the Food and Drug Administration (FDA).

The Edwards SAPIEN™ THV is a prosthetic heart valve, meaning that it is an artificial device, made to replace diseased aortic heart valves.  The valve consists of a stent (made of stainless steel) to hold the device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart.  The implantation of the valve does not require open-heart surgery and can be done in a catheterization laboratory (as used for balloon angioplasty procedures) by a transfemoral approach (through the leg) or transapical approach (through an incision in the chest to access the heart directly).

Participation in this study will last for a minimum of 5 years with at least 7 follow-up visits, which occur at Northwestern Memorial Hospital (NMH).