CoreValve Research Trial
Iowa Heart Center at Mercy is the only site in Iowa, and one of 40 hospitals across the U.S., to participate in the trial the Medtronic CoreValve® U.S. Clinical Trial. This study is evaluating a revolutionary non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery for patients with severe aortic stenosis.
In the clinical trial, physicians channel a catheter (thin tube) with a prosthetic valve through a small opening in the patient’s femoral artery to reach the heart. The physician guides the CoreValve System to the aortic valve, where it self-expands to replace the diseased aortic valve; the procedure is completed without open-heart surgery or surgical removal of the native valve.
In the U.S., the CoreValve System will not be commercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA). The CoreValve System received CE (Conformité Européenne) Mark in Europe in 2007.
For more information, please contact our research department at (515) 633-3842.
Patient Information for the Medtronic CoreValve U.S. Pivotal Trial