SHIELD
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
AI Description
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
- Who can join
- adult, older adult
- Participants
- 500
- Expected completion
- 2027-01
- Funded by
- industry
Conditions studied
Aortic Diseases, Aortic Stenosis Treated With TAVI
What is being tested
- DEVICE: F2 Filter and Delivery System
- PROCEDURE: Transcatheter Aortic Valve Replacement (TAVR)
What it measures
- Major Adverse Cardiac and Cerebrovascular Events (MACCE), MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3), 30 days post procedure
- Total New Lesion Volume, Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI), 8-72 hours post procedure
Working with
Avania, Insight Medical Consulting
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Ascension St. Vincent Hospital (Indianapolis)
Indianapolis, IN
Cleveland Clinic
Cleveland, OH
Henry Ford Health (Detroit)
Detroit, MI
Naples Comprehensive Health (NCH)
Naples, FL
OhioHealth Riverside Methodist Hospital
Columbus, OH
Saint Luke’s Hospital of Kansas City
Kansas City, MO
University Medical Center
Charlottesville, VA
Registry entry updated 2025-11-20
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.