Fletcher Allen, a Vermont university hospital and medical center, serves all of
Vermont and the northern New York region. Located in Burlington, Fletcher Allen is a regional, academic healthcare center and teaching hospital in alliance with the University of Vermont.
Fletcher Allen Announces First Implant in Clinical Trial to Evaluate Revolutionary Heart Valve Procedure
New Technology Designed
to Treat Aortic Heart Valve Disease without Surgery
BURLINGTON, VT – Fletcher Allen Health Care today announced that on February 22 it successfully performed its first two patient implants in the Medtronic CoreValve® U.S. Pivotal Trial. Fletcher Allen Health Care is one of 45 sites in the United States participating in an important clinical study 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, sponsored by Medtronic, 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, 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.
more information on the trial at Fletcher Allen see http://www.fletcherallen.org/services/heart_health/clinical_trials/tavi_clinical_trial/
About Aortic Stenosis
Aortic stenosis, which is most prevalent in the elderly population, inhibits blood flow between the heart and the body and causes symptoms such as shortness of breath, chest pain, fatigue and heart palpitations. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Other than surgery, patients with this condition have had few, if any, successful treatment options.
About Fletcher Allen
Fletcher Allen Health Care, together with our partners at the University of Vermont College of Medicine and the College of Nursing and Health Sciences, is Vermont’s academic medical center. Fletcher Allen and Central Vermont Medical Center are members of Fletcher Allen Partners, established to develop a more coordinated system of care throughout the region. Fletcher Allen’s mission is to improve the health of the people in the communities it serves by integrating patient care, education and research in a caring environment. Fletcher Allen also serves as a regional referral center -- providing advanced care to approximately one million people in Vermont and northern New York -- and as a community hospital for approximately 150,000 residents in Chittenden and Grand Isle counties. For more information about Fletcher Allen, find us online at http://www.fletcherallen.org or on our Facebook, Twitter, YouTube, and blog sites at www.fletcherallen.org/socialmedia.
Physicians are available for interviews to discuss the clinical trial. Broadcast quality animation is also available. Information about the clinical trial is available at www.clinicaltrials.gov.