PREDICT-LAA Trial Enrolls First Patient to Study FEops HeartGuide Computer Simulation Device
January 17, 2020—FEops announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. Headquartered in Gent, Belgium, FEops is focused on personalized predictive planning for structural heart interventions.
According to the company, the trial aims to assess whether the use of its FEops HeartGuide computer simulation based on cardiac CT imaging can contribute to improved preprocedural planning and procedural outcomes of percutaneous left atrial appendage (LAA) closure with the Amplatzer Amulet device (Abbott). The trial is supported by both Abbott and FEops.
PREDICT-LAA is a prospective, multicenter, randomized controlled trial. The trial will enroll 200 patients who are eligible for percutaneous LAA closure with an Amplatzer Amulet device. It will allocate 100 patients 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. The estimated enrollment completion date is March 2021, advised the company.
The PREDICT-LAA trial is led by Principal Investigator Ole De Backer, MD, of Righshospitalet in Copenhagen, Denmark. Dr. De Backer commented in the company's announcement, “Today 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.”
The FEops HeartGuide is a cloud-based procedure planning environment for structural heart interventions that provides physicians with insights to evaluate device sizing and positioning preoperatively using novel computational modeling and simulation technology. The information is intended to improve clinical outcomes in real-world hospital settings.
The current release includes workflows for transcatheter aortic valve replacement and LAA occlusion procedures. The FEops HeartGuide is currently available in the European Union and Canadian markets, advised the company.