Department of Medicine
Dauerman Leads TAVI Clinical Trial
New Technology Designed to Treat Aortic Heart Valve Disease without Surgery
- By Mike Noble
On February 22, 2012 a team of specialists led by UVM/Fletcher Allen cardiologists Harold Dauerman, MD, and Joseph Schmoker, MD, replaced the aortic valves of two patients at Fletcher Allen Health Care, one of a select group of clinical sites now participating in a new U.S. clinical trial to evaluate a revolutionary treatment for a common heart disease, severe aortic stenosis. Vermont’s academic medical center is one of 45 sites in the United States participating in the Medtronic CoreValve® U.S. Pivotal Trial evaluating the safety and effectiveness of a new technology that enables aortic valve replacement without traditional open-heart surgery.
Many patients with severe aortic stenosis are unable to receive surgical valve therapy. For patients at high-risk for open-heart surgery, this trial will study the efficacy of a less-invasive, percutaneous treatment option. Every high risk patient who is considered for the clinical trial will be evaluated by a comprehensive Heart Team including interventional cardiologists and cardiac surgeons.
This clinical trial aims to demonstrate the safety and efficacy of the Medtronic CoreValve® System, an investigational technology that enables aortic valve replacement without the need for traditional open-heart surgery (Transcatheter Aortic Valve Implantation—TAVI). This system allows access to the diseased aortic valve via a femoral artery in the leg and does not require heart-lung bypass.
“There is significant need for a new treatment option for patients with aortic stenosis, and it is enormously rewarding that Fletcher Allen can be part of evaluating this revolutionary new treatment option in our community,” said Harry Dauerman, M.D., director, Cardiovascular Catheterization Laboratories at Fletcher Allen and professor of medicine at the University of Vermont College of Medicine. “As the population ages,” he continued, “the need for this procedure will continue to grow, as aortic stenosis is a condition that develops with age, and many people who are otherwise healthy could benefit significantly.”
In the U.S., the CoreValve System will not be commercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA). The CoreValve System received CE (Conformité Européenne) Mark in Europe in 2007.
“Because open-heart surgery is the most commonly available treatment option for these patients, and because the risks of surgery can be significant for many patients, the medical community is enthusiastic about the less-invasive option for these patients,” said Dr. Dauerman.
For more information about the Medtronic CoreValve U.S. Clinical Trial, see www.aorticstenosistrial.com.
For more information on the trial at Fletcher Allen see http://www.fletcherallen.org/services/heart_health/clinical_trials/tavi_clinical_trial/.