Friday, January 12, 2018
LivaNova PLC, a market-leading medical technology company, today announced that the first patient has been enrolled in the Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-Surgical Aortic Valve Implant Study (“BELIEVE”). This study is a post-market, prospective, interventional, multi-center trial designed to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve.
“Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or open surgical procedures and may lead to leaflet thickening and immobility,” said Dr. Brian Duncan, LivaNova’s Vice President of Medical Affairs in Cardiac Surgery. “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 BELIEVE study is expected to enroll approximately 230 patients at 15 sites from the U.S. and Canada to ascertain whether valve leaflets are fully operational following surgery. 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.
“The BELIEVE study is designed to enhance the understanding of reduced leaflet motion phenomenon, while providing important information to clinicians and patients to ensure the best possible outcomes after surgical aortic valve replacement,” said Dr. Basel Ramlawi, who enrolled the first patient in BELIEVE and is the attending cardiothoracic surgeon and chairman of The Heart & Vascular Center at Valley Health System in Winchester, Va., in the U.S.
In addition to BELIEVE, LivaNova is sponsoring two global studies to advance clinical evidence for aortic valve replacement. The Sorin Universal Registry on Aortic Valve Replacement (“SURE-AVR”) is a post-market, international, prospective, multi-center observational registry collecting clinical outcomes data from up to 5,000 patients implanted with LivaNova aortic devices (bioprosthetic or mechanical). Currently, more than 1,400 patients have been enrolled in the registry from 35 active sites in 13 countries. U.S. sites are currently being activated within this registry, which will follow all patients through five years of follow-up.
The Perceval® Sutureless Implant vs. Standard Aortic Valve Replacement (“PERSIST-AVR”) Study is a global, randomized controlled trial in the surgical treatment of aortic valve replacement. More than 1,200 patients will be randomized to receive either a LivaNova sutureless valve, Perceval, or a standard, sutured, stented bioprosthetic valve on market (LivaNova or other). Currently, more than 570 patients have been enrolled in the study from 43 active sites in multiple countries. U.S. sites are currently being activated within this study, which will follow all patients through five years of follow-up. The primary endpoint of the study is one year freedom from major adverse cardiovascular and cerebral events (composite endpoint of all cause deaths, myocardial infarction, stroke and valve-related re-intervention).
