Belgium-based FEops has announced that the physician-initiated PREDICT-LAA trial has enrolled its first patient to evaluate the use of its HEARTguide computer simulations.
The prospective, multicentre and randomised controlled trial has been carried out at the Rigshospitalet hospital in Copenhagen, Denmark.
The trial will evaluate if the application of HEARTguide computer simulations based on cardiac CT-imaging will result in improved preprocedural planning and enhanced procedural outcomes of percutaneous LAA closure procedures with the Abbott Amplatzer Amulet device.
PREDICT-LAA trial will enrol 200 patients eligible for percutaneous LAA closure with an Amplatzer Amulet device.
FEops will register 100 patients to the computational simulation treatment arm and the remaining 100 patients to the standard treatment arm.
The presence of device-related thrombus and closure of the LAA are the primary endpoints in the trial.
FEops plans to complete the enrolment by March 2021.
PREDICT-LAA principal investigator Dr Ole De Backer said: “Today we enrolled the first patient in PREDICT-LAA at our hospital. In a joined effort with 9 other sites, we will test the hypothesis that by using these new computer simulations, 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.”
FEops HEARTguide is a one-in-its-kind cloud-based procedure-planning environment for structural heart interventions. Currently, it is available in the EU and Canadian markets, offering physicians better insights to assess device sizing and positioning pre-operatively by using computational modelling and simulation technology.
The insights will help to improve clinical outcomes in actual hospital settings.
The current release comprises workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAo) procedures.
FEops director for therapy development Christian Vincent said: “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.”