Feasibility and Safety Study of the Point-Guard Embolic Protection Device During Transcatheter Aortic Valve Replacement TAVR

What this Trial Is About

This research aims to evaluate the safety and feasibility of the Transverse Medical, Inc. Point-Guard device, a cerebral embolic protection device used during Transcatheter Aortic Valve Replacement TAVR procedures. This limited clinical investigation focuses on assessing the devices design, safety, and functionality in patients undergoing TAVR for aortic valve stenosis. The study is prospective, single-arm, multi-center, and open-label, conducted to monitor the devices clinical performance during TAVR. Participants will receive the Point-Guard cerebral embolic protection device as part of their TAVR procedure, with the device used to potentially reduce embolic events during the intervention. The study includes only transfemoral access for TAVR and excludes other access routes. The investigational device will be delivered and retrieved during the TAVR procedure, with no comparator group. The study is sponsored by Transverse Medical, Inc. During the study, participants will be monitored from the start of the TAVR procedure through 30 days post-procedure to assess primary safety endpoints. Follow-up evaluations will include clinical assessments and safety monitoring to evaluate device functionality and patient outcomes. Participants must comply with scheduled follow-ups and provide informed consent, with the total participation lasting at least 30 days after the TAVR procedure.

Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)