Safety and Effectiveness Study of the Resonova CHORDS Cerebral Protection System Compared to Sentinel System During Transcatheter Aortic Valve Replacement

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Resonova CHORDS Cerebral Protection System during Transcatheter Aortic Valve Replacement TAVR. This randomized controlled trial will compare the CHORDS system to the Sentinel Cerebral Protection System in capturing and removing embolic debris to potentially reduce the risk of stroke and other complications. The study will enroll 240 participants with symptomatic severe aortic stenosis who are scheduled for TAVR. Participants will be randomly assigned to undergo TAVR with either the CHORDS Cerebral Protection System test group or the Sentinel System control group. Both groups will have the device used during their TAVR procedure. The study includes follow-up visits at 30 and 90 days after the procedure to assess outcomes and safety. During the trial, participants will be monitored with brain MRI scans between 2 to 7 days post-procedure to measure new lesion volumes. Clinical assessments will measure major adverse cardiac and cerebrovascular events MACCE at 30 days, along with procedural and device success rates immediately after the procedure. Additional evaluations include neurological function scores and vascular complications up to 90 days post-procedure. Participants will be followed closely to assess safety and effectiveness over the course of the study.

Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial