Alternative Treatment for Patients Needing Open Heart Surgery for their Aortic Valve

What we are studying

The aortic valve is one of the four heart valves that control the flow of blood into and out of the heart. The aortic valve lets oxygen-containing blood to be pumped out of the heart, from the left ventricle (main pumping chamber of the heart) into the aorta (main artery delivering blood to the body). If the valve becomes abnormally narrow through a process of thickening and stiffening (aortic stenosis) the heart must work harder to pump the same amount of blood with each beat. As the heart works harder, the heart muscle thickens (hypertrophy), and the heart chamber (ventricle) may become larger (dilate). Open-heart surgery to replace the diseased aortic valve is the standard treatment. As an alternative to open heart surgery, the Medtronic CoreValve® System has been developed to replace a diseased aortic heart valve without the need for open heart surgery. This system allows the percutaneous aortic valve (study valve) to be implanted (inserted) through a long, thin flexible tube that is inserted through an incision in the skin and threaded through the bloodstream (percutaneous). The purpose of this clinical study is to determine if replacing the aortic valve without open-heart surgery is as safe as or safer than open-heart surgery.

Who we are studying

Men and Women
Races:
- White
- African American
- Asian
- American Indian or Alaska Native
- Native Hawaiian or Pacific Islander
- Other
All Ethnicities
Ages 18+

Eligibility Criteria

Severe aortic valve stenosis
Need a physician referral which confirms diagnosis of severe aortic stenosis

What is involved

Study participation will last approximately 5 years
1 screening visit
Follow up visits will occur at 30 days; 6 months; 12 months; 18 months; 24 months; 3 years; 4 years; and 5 years after the procedure