StudyFinder
THE SHIELD STUDY: A PROSPECTIVE, RANDOMIZED, MULTICENTER, SINGLE-BLIND TRIAL TO ASSESS THE SAFETY AND EFFECTIVENESS OF THE ENCOMPASS F2 CEREBRAL PROTECTION SYSTEM VS. STANDARD OF CARE (UNPROTECTED OR SENTINEL? CEREBRAL PROTECTION SYSTEM) DURING TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TF TAVR)
Status: Recruiting
Comparing the safety and effectiveness of the study device, the F2 Cerebral Protection System (accessory used during procedure for brain protection), to our facility's standard of care control group (where no accessory is used) during transfemoral transcatheter aortic valve replacement procedure.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• Age 21-90 years old
• Eligible for transcatheter aortic valve replacement via transfemoral access
• Scheduled for transcatheter aortic valve replacement per physician
Exclusion Criteria:
Requiring emergent valve replacement, heart attack within 3 months, prior prosthetic heart valve replacement, blood clot in the heart, active infection, unable to take anticoagulant/antiplatelet medications, significant kidney or liver disease, pregnant or nursing, stroke/stroke-like event within 6 months, severe visual/hearing/learning impairment, significant debility, unable to have MRI for any reasonInterventions:
Drug/Device: F2 Cerebral Protection System
Conditions:
Those indicated for TF TAVR
Keywords:
F2 filter, severe aortic stenosis, stroke prevention, TAVR
Contact(s): Sara Poggio - spoggio1@hfhs.org
Principal Investigator: Brian O'Neill
Principal Investigator ID: boneil3@hfhs.org
Phase: II/III
See this study on ClinicalTrials.gov