LivaNova PLC commences BELIEVE Aortic Heart Valve Study
LivaNova PLC commences its enrollement of patients in the Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-Surgical Aortic Valve Implant Study (“BELIEVE”). A trial designed to hint the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve.
Dr. Brian Duncan, LivaNova’s Vice President of Medical Affairs in Cardiac Surgery claimed “BELIEVE is the first trial to examine this process with advanced imaging and a standardized approach to anticoagulation in patients undergoing implantation of LivaNova bioprosthetic aortic valves.”
The study is likely to enlist 230 patients at 15 sites from the U.S and Canada to determine the efficiency if valve leaflets.Four-dimensional, volume-rendered CT scans will be obtained from patients at a minimum of 30 days after they discontinue anticoagulation or dual antiplatelet therapy. There will be one year of follow-up for all patients. In additon to this LivaNova is financing two global studies for aortic valve replacement namely the The Sorin Universal Registry on Aortic Valve Replacement (“SURE-AVR”) and the The Perceval® Sutureless Implant vs. Standard Aortic Valve Replacement (“PERSIST-AVR”) Study .