Bon Secours Richmond Health System announced its first patients have been enrolled in a new expanded indication trial for the CoreValve™Evolut™ R System, a minimally invasive treatment for patients with failing aortic heart valves. Patients with severe aortic stenosis who are at a low surgical mortality risk as determined by the Bon Secours heart team will be considered for enrollment in the trial. Patients approved for the study will be randomized on a 1:1 basis to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement. To date, the technology is commercially approved only for patients with severe aortic stenosis who are considered at high or extreme risk for surgery.
The new trial is currently only available in the Greater Richmond Region at Bon Secours St. Mary’s Hospital and is led by the Bon Secours Heart and Vascular Institute physicians D. Scott Lim, M.D. and Mark Bladergroen, M.D.
The Evolut R System is a next-generation TAVR system commercially available in the United States for patients with severe aortic stenosis who are considered at high or extreme risk for surgery. The system was designed to increase the potential for optimal device placement during TAVR by providing physicians the option to recapture the valve and reposition it during the procedure.
“More than 100,000 people in the United States are diagnosed with severe aortic stenosis each year,” said Dr. Lim. “The most common cause of aortic stenosis is excessive wear on the aortic valve. This usually develops with age, but the process may be expedited in patients who are congenitally predisposed to disease.”
“Symptoms can vary and change over time, but can include: fatigue, dizziness, chest pain, shortness of breath during activity, heart palpitations and fainting,” said Dr. Bladergroen. “If left untreated, severe aortic stenosis can lead to serious heart problems, including heart failure and even death.”
The investigational device exemption (IDE) trial will include 1,200 patients with severe aortic stenosis who have a less than three percent risk of mortality after open-heart surgery, as determined by a heart team. Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets.
When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.
The CoreValve Evolut R System replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve’s function to help enable oxygen-rich blood to flow more efficiently out of the heart.
The CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System were FDA-approved for commercial use in the United States in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery. The device is investigational for this study and patient population.
For more information about aortic stenosis and the trial, please call (804) 287-7843.
CAUTION: Investigational device. Limited by Federal Law (USA) to Investigational Use; Exclusively for Clinical Investigations”
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About Bon Secours Richmond Health System
Bon Secours Richmond is part of Bon Secours Virginia, which provides good help to thousands of Virginians through a network of hospitals, primary and specialty care practices, ambulatory care sites and continuing care facilities across the Commonwealth. The not-for-profit health system employs more than 8,400 people, including nearly 420 providers as part of the Bon Secours Medical Group.
The fourth largest and only faith-based health system in Virginia, Bon Secours Virginia offers a full range of services including cardiac, women’s, children’s, orthopaedics, oncology, neurosciences and surgery at eight award-winning hospitals.
- ·Bon Secours Richmond is St. Mary’s Hospital, Memorial Regional Medical Center, Richmond Community Hospital, Rappahannock General Hospital and St. Francis Medical Center.
- ·Bon Secours Hampton Roads is Maryview Medical Center, DePaul Medical Center and Mary Immaculate Hospital.
About Bon Secours Virginia Health Care Foundation
The Bon Secours Virginia Health Care Foundation raises charitable funds to help Bon Secours Virginia Health System address the community’s growing health care needs with compassion and excellence. Through charitable support, we are dedicated to helping create healthy communities, advancing clinical innovation and providing an extraordinary experience of care. For more information on giving, visitwww.bsvaf.org.