Piedmont Heart Institute Physicians are currently accepting patients for the Medtronic CoreValve U.S. Clinical Trial. Piedmont Hospital is one of 40 hospitals across the United States to participate in the trial to evaluate a revolutionary non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery for patients with severe aortic stenosis.
Patients who have severe aortic stenosis as well as a predicted high risk of requiring aortic valve surgery may be eligible to participate in the clinical trial. For more information about the CoreValve trial and eligibility, visit clinicaltrials.gov and search for the CoreValve trial.
â€œWith an estimated 5 percent of those over the age of 65 experiencing some form of aortic stenosis, there is significant need for new treatment options that do not involve invasive surgery,â€ said Piedmont principal investigator Vivek Rajagopal, M.D., an interventional cardiologist with Piedmont Heart Institute Physicians. â€œAs the population ages, the need for this procedure will continue to grow.â€
According to an abstract published in the European Heart Journal in 2003, worldwide, approximately 300,000 people have been diagnosed with this condition (100,000 in the United States), and approximately one-third of these patients are deemed high risk for open-heart surgery, the only therapy with significant clinical effect that is currently available in the United States.
For trial participants randomly selected to receive the CoreValve System, physicians channel a catheter (thin tube) with a porcine, prosthetic valve through a small opening in the patientâ€™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 United States, 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 (ConformitÃ© EuropÃ©enne) Mark in Europe in 2007.
For more information or to be considered as a participant in the trial, contact the Piedmont Heart Institute at 404-605-5003 or email firstname.lastname@example.org.