The University of Michigan Cardiovascular Center, a leader in heart valve replacement, will participate in the CoreValve US pivotal clinical trial to offer patients a less invasive approach to replacing diseased aortic valves.
The University of Michigan is among 40 sites in the USA selected for the Medtronic CoreValve clinical trial, a study that will examine an investigational alternative to open heart surgery for patients with severe aortic stenosis.
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.
“Through this trial we are investigating a minimally invasive procedure for the thousands of patients diagnosed each year with severe aortic stenosis,” said G Michael Deeb, cardiac surgeon, University of Michigan. “There is a tremendous unmet need for a safe and effective treatment that will help them live longer and feel better.”
The University of Michigan’s study team will be lead by Stanley J Chetcuti, associate professor of internal medicine, Paul Michael Grossman, associate professor of internal medicine, G Michael Deeb, Herbert Sloan Collegiate professor of surgery and Himanshu J Patel, associate professor of surgery.
They are among the experts in the University of Michigan’s aortic programme that performs over 500 surgical valve procedures a year.
In the CoreValve trial, surgeons and interventional cardiologists work together to perform the transcatheter aortic valve implantation. It allows access to the diseased aortic valve percutaneously, 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 CoreValve system or open heart surgical aortic valve replacement surgery.
Chetcuti, co-principal investigator of the study and director of the cardiac catheterization laboratory at the Cardiovascular Center said, “The critical part of the study is to make sure it is done well and that we answer the questions: Is this technology safe and does it make a difference to our patients.”
The trial adds to the University of Michigan 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.