IRB Study Number 25-374
Status Recruiting
Institute Heart and Vascular Institute
Description
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS; treatment group) to a standard of care control group in participants undergoing TF TAVR with commercially available devices.
Inclusion Criteria
Age ≥ 50 years.
Patient meets the established criteria and indications for commercially available TAVR (e.g., balloon expandable SAPIEN valve platform, self-expanding CoreValve platform, or Navitor TAVI System) via transfemoral access and is scheduled to undergo TAVR per their treating physician.
Patient is willing and able to comply with protocol-specified follow-up evaluations.
Exclusion Criteria
Patient requires an urgent or emergent TAVR procedure.
Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure (e.g., pacemaker placement, BAV, PCI) or planned within 30 days post-TAVR procedure.
Current or planned participation in any investigational device/biopharma study during the duration of this study protocol.
