Providence Sacred Heart Medical Center is one of 40 hospitals nationally enrolling patients in a clinical trial scheduled to start this month to test a new heart-valve replacement device.

The Medtronic CoreValve System, marketed by Minneapolis-based Medtronic Inc., is inserted through a minimally-invasive catheter procedure and is designed to replace a patient's diseased aortic valve.

"What's revolutionary about this device is it allows you to restore normal valve function without having to do conventional open-heart surgery," says Dr. Michael Ring, a cardiologist who is a lead co-investigator along with Dr. Leland Siwek, a cardiovascular surgeon.

Sacred Heart has its first three patients scheduled for surgery later this month, and the clinical trial is expected to last about a year and a half.

The same Medtronic device is used in Europe and now approved in more than 35 countries. The FDA approved the U.S. clinical trial protocol for the CoreValve device in 2010.

The device will be implanted in patients with severe aortic stenosis, a disease that affects the aortic valve of the heart and prevents it from properly opening and closing.

When an aortic valve is narrowed, it restricts blood flow from a patient's heart to his or her body.

Doing this less invasive procedure allows for treatment of those with aortic stenosis who are otherwise inoperable or aren't considered good candidates for open-heart surgery, Ring says.

"Because it's a condition that often afflicts elderly patients, they may be frail or have other medical conditions that make conventional open-heart surgery a much higher risk," he says.

The procedure typically involves an incision of about three-quarters of an inch in a patient's groin area in which a catheter can be inserted.

Consequently, recovery is expected to be much faster than with conventional surgery, Ring says.

"I think most patients will be significantly improved in a matter of days to weeks," he adds.

People with aortic stenosis, once they develop symptoms such as shortness of breath, typically will live only about two years without medical intervention, Ring says.

Siwek says the study also involves a comparison group of patients considered at high risk for open-heart surgery, with about half randomly selected to do the new procedure and the others undergoing the conventional surgery.

Doctors have diagnosed about 100,000 people in the U.S. with aortic stenosis.

About 1,300 patients nationwide will be involved in the study, and Ring says Sacred Heart hopes to enroll about 35 to 40 patients.

Siwek says a major factor toward Spokane's selection for the study is the hybrid operating room facility where doctors will perform the procedure, which is in an area equipped for both surgical treatments and X-ray-guided imaging similar to what's found in a radiology suite.

At Sacred Heart, a team of about 10 medical professionals will be involved in the study treatment, Ring says, including Dr. Branden Reynolds, a surgeon, and Dr. Brad Batkoff, a cardiologist, as well as anesthesiologists, radiologists, and a dedicated operating room crew trained to perform the procedure.

Ring also asserts that this approach is an example of how cardiologists and cardiovascular surgeons will be working together in the future.

"That's relatively new," he says. "Really, what this is leading to is a team involving a hybrid approach to treating heart disease, a blending of interventional cardiology skills with conventional cardiac surgery skills."