Study of EmStop Embolic Protection System Compared to Sentinel Device for Safety and Effectiveness During Transcatheter Aortic Valve Replacement in Adults with Severe Aortic Valve Stenosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the EmStop Embolic Protection System during self-expanding transcatheter aortic valve replacement TAVR procedures in people with severe aortic valve stenosis. This prospective, single-blind, multi-center, randomized study compares the EmStop device to the Boston Scientific Sentinel device to see how well each captures and removes embolic debris during the procedure. The study is conducted in up to 25 U.S. sites and follows participants for 30 days after their TAVR. Participants are randomly assigned in a 21 ratio to receive either the EmStop Embolic Protection System or the Sentinel device during their TAVR procedure. Both devices are used to capture and remove thrombus or debris that may occur during the valve replacement. The study requires specific anatomical compatibility confirmed by imaging tests such as echocardiogram and computed tomography angiography CTA before randomization. The procedures are performed on weekdays Monday through Thursday to allow neurological assessments. During the study, participants will undergo assessments including echocardiograms and CT angiography to confirm suitability before the procedure. After the valve replacement, they will be monitored for up to 30 days to evaluate major adverse cardiac and cerebrovascular events MACCE and debris capture by the devices. Researchers will track safety and efficacy outcomes, including comparison of event rates between the two device groups. Participants will be followed closely during this period to record any complications or adverse effects.

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material