Learn more about a U-M clinical study for the treatment of severe aortic stenosis
The nationally ranked U-M is among 40 sites in the nation selected for the Medtronic CoreValve U.S. Pivotal trial, a study that will examine an investigational alternative to open heart surgery for patients with severe aortic stenosis.
Physicians with the U-M aortic program performed the implantation of the Medtronic CoreValve Transcathetic Aortic Valve prosthesis on three patients, April 28-29. Designed to replace a diseased aortic heart valve percutaneously via a catheter, the procedure potentially provides a safe and less invasive alternative to open heart surgery.
The U-M study team is lead by Stanley J. Chetcuti, M.D., director of the cardiac catherization lab at the U-M Cardiovascular Center, Paul Michael Grossman, M.D., director of the cardiac catherization lab at the VA Ann Arbor Healthcare System; G. Michael Deeb, M.D., director of the multidisciplinary aortic clinic and the Herbert Sloan Collegiate professor of surgery, and Himanshu J. Patel, M.D., associate professor of surgery.
They are among the experts in the U-M aortic program that performs over 500 surgical valve procedures a year, which is more than any other Michigan program.
Aortic stenosis is a condition where the aortic valve narrows, thereby limiting blood flow from the aorta to the rest of the body. Left untreated, aortic valve stenosis can lead to serious heart problems, including heart failure and even death.
About 100,000 Americans, most of them over the age of 70, are diagnosed with severe aortic stenosis each year, but one-third of patients, because of age or frail health, are considered too high-risk for traditional surgery.
In the CoreValve trial, surgeons and interventional cardiologists work together to perform the implantation on the patients who have limited surgical options. The procedure allows access to the diseased aortic valve through the skin, usually an artery in the leg, rather than through open surgery.
The CoreValve trial will involve up to 1,200 patients nationwide who are randomly assigned to one of two treatment options: the Core Valve system or open heart surgical aortic valve replacement surgery.
The trial adds to the U-M Cardiovascular Center’s tradition of research expertise. In the past five years alone, its physicians and scientists have participated in more than 700 cardiovascular clinical trials.
To learn more about the Medtronic Core Valve U.S. Pivotal Trial, call (877) 885-8444.