Belgium-based FEops has recruited the first patient in the physician-initiated PREDICT-LAA trial, which will evaluate the efficacy of the HEARTguide computer simulations.
The prospective, multicentre and randomised trial has commenced at the Righshospitale hospital situated in Copenhagen, Denmark.
The trial will evaluate whether the application of HEARTguide computer simulations based on cardiac CT-imaging will result in better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with the Abbott Amplatzer Amulet device.
FEops will recruit 200 patients in the PREDICT-LAA trial
The PREDICT-LAA study will enrol 200 patients eligible for percutaneous LAA closure with an Amplatzer Amulet device.
The company will allot 100 patients to the computational simulation treatment arm, while the remaining 100 patients to the standard treatment arm.
The presence of the LAA and device-related thrombus are the primary endpoints in the trial. FEops aims 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, 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.”
FEops HEARTguide, which is already available in the EU and Canadian markets, is a one-in-its-kind cloud-based procedure planning environment for structural heart interventions. In April 2019, FEops secured CE mark approval for its HEARTguide.
It offers physicians with insights to assess device sizing and positioning pre-operatively by using new computational modelling and simulation technology. The insights will help improve clinical outcomes in real-world hospital settings.
Workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAo) procedures are included in the current release of the product.
FEops therapy development director 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.”
