Study Looking at Aortic Stenosis and an Investigational Valve Device

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. 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. For some patients, the risk of experiencing major complications during open-heart surgery is very high. These patients are considered extreme risk or at very high risk to have an operation. The standard treatment for extreme risk patients with symptoms of severe aortic stenosis is medical management. As an alternative to medical management, 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 research study is to evaluate the valve. The study valve is considered an "investigational device", which means that clinical studies are required to determine if it is safe and provides clinical benefit.

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

  • Diagnosed with aortic stenosis
  • Doctors have decided your risk of experiencing major complications while undergoing open-heart surgery is very high due to medical reasons or anatomical (relating to how and where your heart
  • Aortic valve and blood vessels are placed within your body) reasons

What is involved

  • 1 screening visit
  • 1 baseline visit prior to the placement of the valve; Valve procedure; Follow-up visits will occur at: 30 days; 6 months; 1 year; 2 years; 3 years; 4 years; and 5 years

Compensation

Participants will be reimbursed for local mileage based on the IRS guidelines at the time of payment (currently 55.5 cents/per mile not to exceed $50.00 per visit) and parking expenses directly related to any study related visits

Contact Information

Study Coordinator
Travis Young
Email
tryoung@wakehealth.edu
Phone
336-713-4431

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.