FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. The trial, which is led by Righshospitalet (Copenhagen, Denmark), aims to assess whether the use of FEops HEARTguide computer simulations (based on cardiac CT imaging) can contribute to better preprocedural planning and improved procedural outcomes of percutaneous left atrial appendage (LAA) closure procedures with the AmplatzerAmulet device (Abbott). The trial is supported by both Abbott and FEops.
PREDICT-LAA is a prospective, multicenter, randomized controlled trial. In total, 200 patients eligible for percutaneous LAA closure with an Amplatzer Amulet device will be enrolled—100 patients will be allocated to the computational simulation treatment arm and 100 patients to the standard treatment arm. Primary endpoints are closure of the LAA, and presence of device-related thrombus. Estimated enrolment completion date is March 2021.
Ole De Backer (Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen), principal investigator of the PREDICT-LAA, comments: “We enrolled the first patient in PREDICT-LAA at our hospital. In a joined effort with nine other sites, we will test the hypothesis that by using these new computer simulations, a better preprocedural planning of the intervention can be obtained. This is essential information, since today it is not always possible to determine the exact anticipated ‘landing zone’ or ‘position’ of the closure device and, hence, to select the appropriate device size.”
Christian Vincent, director Therapy Development at FEops, states: “Our support together with Abbott in the PREDICT-LAA trial shows our strong commitment to generate a robust body of clinical evidence with FEops HEARTguide, contributing to better procedure planning and patient outcome.”
FEops HEARTguide, currently available on the EU and Canadian market, is a cloud based procedure planning environment for structural heart interventions that aims to provide physicians with unique insights to evaluate device sizing and positioning pre-operatively using novel computational modelling and simulation technology. Such insights could have the power to help improving clinical outcomes in real-world hospital settings. The current release includes workflows for transcatheter aortic valve implantation (TAVI) and LAA closure procedures.