Banner Good Samaritan Medical Center Begins Study of Alternative Therapy to Open-Heart Aortic Valve Surgery
Banner Good Samaritan Medical Center is one of a select group of clinical sites now participating in a new U.S. clinical trial to evaluate a revolutionary treatment for a common heart disease, severe aortic stenosis. The clinical trial, locally led by principle investigators Drs. Timothy Byrne and Michael Caskey, is evaluating the Medtronic CoreValve® System as a non-surgical, minimally invasive treatment option for patients with severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery.
Approximately 100,000 Americans and 300,000 people worldwide have been diagnosed with severe aortic stenosis, and one-third of these patients are deemed at too high a risk for open-heart surgery. According to research, without effective treatment, as many as 50 percent of aortic stenosis patients with severe symptoms die within one year.
“Banner Good Samaritan is proud to participate in the CoreValve U.S. Clinical Trial to help evaluate the safety and effectiveness of this novel therapy for people who are in significant need of aortic valve replacement – but currently have few or no options,” said Dr. Michael Caskey. “It’s an example of our leadership in studying forward-looking treatments and enhancing our cardiac care offerings to our community.”
The CoreValve System replaces a diseased aortic valve percutaneously, usually through a small opening in the femoral artery. The procedure is typically referred to as transcatheter aortic valve implantation (TAVI). The device is made from porcine cardiac tissue fixed on a frame made of Nitinol, a shape memory alloy with super-elastic properties.
“The procedure we are evaluating does not require open-heart surgery or surgical removal of the native valve, which makes this potential treatment option especially desirable because so many patients with aortic stenosis are not able to withstand surgery,” said Dr. Timothy Byrne.
The CoreValve System was first approved for use in Europe in 2007. CoreValve is not yet approved for commercial use in the U.S. This clinical trial will evaluate and compare options for patients in the U.S. with severe aortic stenosis. Candidates will be screened and rated based on their level of severity. Those who are classified as extremely high risk (inoperable) will receive the CoreValve. All other patients will be randomized for either TAVI or conventional aortic valve replacement surgery.
Patients interested in learning about the clinical trial occurring at Banner Good Samaritan should contact the research office at (602) 839-5674. Additional information about the U.S. CoreValve study is available at www.clinicaltrials.gov and www.aorticstenosistrial.com.