Medical breakthrough CoreValve® study may provide new options for patients who cannot have surgery.
Atlanta, GA (March 1, 2011)— After a national review of vying hospitals, Medtronic has named Saint Joseph’s Hospital of Atlanta as a selected site to participate in its pivotal Medtronic CoreValve® U.S. Clinical Trial. The device could provide a new therapy for patients with aortic stenosis who are considered inoperable.
“Being accepted into this trial recognizes Saint Joseph’s among a select number of leading hospitals in the country,” said Louis Heller, MD. “We’re excited Medtronic has chosen us to conduct its clinical trial, which we believe has all the potential of creating the next major medical breakthrough in cardiology and cardiac surgery.”
As a participating site in this nationwide clinical trial, Saint Joseph’s cardiologists and cardiac surgeons will be evaluating a new, non-surgical alternative to open-heart surgery for patients with severe aortic stenosis (abnormal narrowing of the aortic valve) who are at high risk for surgery or cannot have surgery. During the catheterization, cardiologists will replace a patient’s failing aortic valve with the prosthetic CoreValve which uses self-expandable technology to deploy inside the diseased aortic valve, effectively eliminating the need for open-heart surgery or surgical removal of the native valve. Once the CoreValve is in place, it takes over the native valve’s function, ensuring that oxygen-rich blood flows into the aorta and circulates throughout the body.
“By participating in this trial, Saint Joseph’s cardiologists and cardiac surgeons are among the country’s leading cardiac specialists pushing the boundaries of medical treatment to benefit patients in need,” said Steven Macheers, MD. “We are proud to stand with our patients as we embark on this new frontier.”
Approximately 100,000 people in the U.S. (300,000 people worldwide) suffer from severe aortic stenosis and one-third are considered inoperable; currently, surgical replacement is the only therapy with significant clinical effect that is available in the United States.
The Medtronic CoreValve U.S. Clinical Trial will enroll a total of more than 1,300 of these patients through 40 U.S. clinical sites, including SJHA. Saint Joseph’s is currently enrolling patients in the trial. For more information about participating in this clinical trial, contact Rita Campbell, RN, CCRC at 678-843-5578 or Sonya Mathewson at 678-843-6092. Outside the U.S., CoreValve received CE Mark in Europe in 2007. For more information about the Medtronic CoreValve U.S. Clinical Trial, see www.aorticstenosistrial.com.