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)
The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
NCH Baker Hospital-Naples Heart Institute
Naples, Florida, United States
NOT_YET_RECRUITINGSt. Vincent Hospital
Indianappolis, Indiana, United States
RECRUITINGMajor 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)
Time frame: 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)
Time frame: 8-72 hours post procedure
Stroke
Incidence of all stroke events
Time frame: 30 days post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Henry Ford Hospital
Detroit, Michigan, United States
RECRUITINGSt. Lukes Hospital Of Kansas City
Kansas City, Missouri, United States
RECRUITINGCumc/Nyph
New York, New York, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGOhio Health Research Institute (aka Riverside Methodist Hospital)
Columbus, Ohio, United States
NOT_YET_RECRUITINGUniversity of Virginia Medical Center
Charlottesville, Virginia, United States
NOT_YET_RECRUITINGSt Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
NOT_YET_RECRUITINGMonash Health Public
Clayton, Victoria, Australia
RECRUITING