Study Comparing the F2 Cerebral Protection System to Standard Care During Transfemoral Transcatheter Aortic Valve Replacement in Adults 50 and Older

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the F2 Cerebral Protection System CPS compared to standard care in patients undergoing Transcatheter Aortic Valve Replacement TF TAVR. The study aims to show that the F2 CPS is as safe as the control group and superior in effectiveness for protecting the brain during this heart valve procedure. This trial is a prospective, randomized, single-blind study conducted across multiple centers to assess these devices in patients with aortic stenosis and related aortic diseases. Participants will receive either the F2 Cerebral Embolic Protection System or standard care, which may include the Sentinel Cerebral Protection System or no embolic protection device during their TF TAVR procedure. The study compares the new F2 filter device against the current standard of care to see how well it prevents embolic events during the valve replacement. The intervention involves using these devices during the heart procedure to capture debris that might cause stroke. During the study, participants will be monitored closely with assessments including brain imaging to measure new lesion volume within 8 to 72 hours after the procedure and follow-up evaluations up to 30 days post-procedure to track major adverse cardiac and cerebrovascular events, including stroke. Researchers will also evaluate safety and effectiveness through clinical exams and data collection about any complications. Participation involves multiple visits and evaluations to ensure participant safety and collect outcome data over the study period, which continues through January 2027.

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR