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Vanderbilt Heart to participate in CoreValve clinical trial

Apr. 18, 2011, 12:46 PM

Heart illustration
Digital medical illustration: Close-up of human heart with major aorta. (iStock Photo)

Vanderbilt Heart will soon begin testing the safety of a novel, non-surgical approach to treating aortic stenosis, a common heart problem caused by an abnormal narrowing of the heart’s aortic valve.

Today, Vanderbilt announces its participation in the Medtronic CoreValve U.S. Clinical Trial, which will evaluate a new, non-surgical alternative to open-heart surgery for patients with severe aortic stenosis (narrowing). Vanderbilt is now among a select number of leading hospitals across the United States to participate in this trial.

The CoreValve System is designed to provide a minimally invasive option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open heart surgery. Worldwide, about 300,000 people have been diagnosed with this condition (100,000 in the U.S.), and about one-third of these patients are deemed too high a risk for open-heart surgery, the only therapy that is currently available in the United States.

The new valve replacement procedure channels a catheter (thin tube) with an artificial valve through the femoral artery in the groin to reach the heart. The CoreValve System is designed with self-expandable technology, deploying the new valve inside the diseased aortic valve without open-heart surgery or surgical removal of the patient’s original valve.

“While traditional open aortic valve replacement will still have a major role in most low- and moderate-risk patients, trans-catheter valve therapy will probably be preferable in high-risk patients,” said David Zhao, director of the Cardiovascular Catheterization Lab and Interventional Cardiology.

The Medtronic CoreValve U.S. Clinical Trial will enroll more than 1,200 patients at 40 U.S. clinical sites, including Vanderbilt. Zhao and John G. Byrne, the William S. Stoney Professor and chairman of the Department of Cardiac Surgery, are the co-principal investigators. Other Vanderbilt physicians involved in the study include Joseph Fredi, Mark Robbins, Marshal Crenshaw, and Steven Ball.

“Medtronic chose Vanderbilt, in part, because of our integrated cardiovascular service line and high level of collaboration between Cardiology and Cardiac Surgery. Other probable factors were our extensive hybrid OR experience as well as our overall valve volume,” Byrne said. “We will be performing these procedures in our hybrid cath lab/OR, which is really the ideal setting.”

The trans-catheter approach takes 90 minutes vs. three to four hours for open heart surgery, Byrne said.

Learn more about the Medtronic CoreValve U.S. Clinical trial.

Vanderbilt is currently enrolling patients in the trial. For more information about participating in this trial, call 615-343-9188.

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