Belgium-based digital health scale-up FEops has announced that the PREDICT-LAA study demonstrated that its HEARTguide significantly improved efficiency and outcomes of left atrial appendage closure (LAAC) procedures.
According to the company, the study examined procedural efficiency and showed a 15% reduction in the total number of LAAC devices used, as well as a 50% decline in the number of device repositionings.
It also demonstrated a 25% reduction in radiation and contrast medium use, while the procedural time and success without major complications in complete cases were reduced by 20% in the study’s FEops HEARTguide arm.
Furthermore, the trial showed a significant improvement in procedural outcomes with the device, including 40% more complete left atrial appendage (LAA) occlusion with no LAA patency.
The device’s other procedural outcomes included 60% less retraction of the Amplatzer Amulet disc into the LAA and an 80% reduction of device-related thrombus risk.
The study’s principal investigator Dr Ole De Backer said: “PREDICT-LAA is the first prospective trial showing that the accuracy of the selection of the LAAC device size and implant position is significantly better when using FEops HEARTguide as compared to standard CT-sizing.”
PREDICT-LAA is a multicentre clinical study with 200 patients that are randomised in a 1:1 ratio of standard planning versus cardiac computed tomography (CT)-simulation-based planning of LAAC with the Amplatzer Amulet LAA occluder.
FEops co-founder and CEO Dr Matthieu De Beule said: “In 2022, we obtained FDA clearance for FEops HEARTguide LAAO workflow, we became a global digital health player with more than 6,000 patients analysed in over 300 hospitals in 27 countries and we have now, as the first company ever, randomised controlled clinical trial data evidencing the value of digital twin technology in the cardiovascular space.”