TRIGUARD cerebral embolic protection device during TAVI

to investigate the safety and efficacy of TriGuard HDH (TG) cerebral embolic protection device compared to controls in patients undergoing TAVI

prospective, multicentre, single-blind 2:1 (TG vs no TG) randomised trial

patients with symptomatic severe aortic stenosis referred for TAVI

safety endpoint: composite of all-cause death, stroke, severe bleeding, stage 2-3 acute kidney injury, coronary obstruction, major vascular complications, valve related dysfunction at 30 days. efficacy endpoint: all-cause death or any stroke at 30 days, NIHSS or MoCA worsening at 30 days and MRI-lesions.