Second Generation ProtEmbo System for Cerebral Embolic Protection during Transcatheter Aortic Valve Replacement

The incidence of stroke varies in contemporary transcatheter aortic valve replacement (TAVR) studies between 1% in low-risk patients, and up to 2.9 to 10% in intermediate- and high-risk patients. New silent cerebral micro-emboli can be detected in the large majority of patients after TAVR via diffusion-weighted magnetic resonance imaging (DW-MRI).

Left transradial access is used for cerebral embolic protection devices such as the ProtEmbo System, an intra-aortic deflection filter device. The safety and feasibility of the second generation ProtEmbo System is investigated in an open-label, observation, single arm study in AS patients indicated for TAVR. The primary safety endpoint is procedural safety, defined as occurrence of all MACCE based on VARC-2, including device-related safety outcomes. Primary feasibility is defined as technical success using the device. The secondary efficacy endpoint is defined as the reduction in number and volume of new cerebral lesions assessed on DW-MRI at baseline and day 3, compared to a historical group.

The first-in-human cases with the second generation ProtEmbo System will be presented for the first time at ICI including primary and secondary endpoint outcomes.