Northwestern's Bluhm Cardiovascular Institute has enrolled its first participant in SALUS, a clinical trial studying the effectiveness of a prosthetic aortic heart valve that can be placed without open-heart surgery. The heart valve under study, the Direct Flow Medical- Transcathether Aortic Valve System manufactured by Direct Flow Medical, Inc., is a non-metallic, investigational device specifically designed to be placed inside the heart using a catheter that is inserted through a blood vessel in the groin and then navigated into the aorta to the heart. The study valve is also designed to have the unique ability to be repositioned or even replaced with a different size after the valve's initial placement to achieve a better fit if one is needed.
SALUS is the first U.S. clinical trial of the Direct Flow Medical Transcathether Aortic Valve System, and will seek to evaluate how well the test valve can be delivered and its effectiveness once it is in use. Northwestern's enrollment is the first in Illinois and the fourth institute in the country to enroll subjects.
"Aortic stenosis is a condition that commonly affects older individuals. The leaflets of the aortic valve become thick and calcified and ultimately can limit the ability of blood from being pumped out of the heart," said James D. Flaherty, MD, Northwestern Medicine cardiologist and Northwestern's principal investigator for SALUS. "When the narrowing becomes severe, patients develop symptoms such as shortness of breath, fatigue, lightheadedness and chest pain. If uncorrected, their life expectancy is also significantly shortened."
Open-heart surgery has been the gold standard treatment for aortic stenosis since the 1960's. However, many patients are considered high-risk or inoperable for traditional heart surgery. Transcatheter Aortic Valve Replacement (TAVR) is a technique to insert a new aortic valve through catheters instead of open heart surgery. The only transcatheter heart valve that is commercially available in the United States requires larger catheters than the study valve, sits within a metal ring, and cannot be repositioned or replaced once it is released from the catheter.