New brain filter aims to prevent strokes during heart procedure
NCT ID NCT06689839
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a new device called the Encompass F2, which is designed to catch debris that might travel to the brain during a common heart valve replacement procedure (TAVR). The goal is to see if it reduces the risk of stroke and brain damage compared to standard care. About 500 patients with aortic stenosis will be randomly assigned to receive the F2 device or standard care, and their outcomes will be tracked.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- F2 Filter and Delivery System (a cerebral protection device)
- What this could lead to
- If it works, this device could lower the chance of stroke and brain injury during TAVR, making the procedure safer for patients with aortic stenosis.
- What could go wrong
- This is an early-stage device trial with no phase designation, so results may not confirm benefit. There is also a risk of complications from the device itself, such as vascular injury or device-related stroke.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Cumc/Nyph
RECRUITINGNew York, New York, 10032, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
Contact Email: •••••@•••••
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Monash Health Public
RECRUITINGClayton, Victoria, 3168, Australia
Contact
Contact Email: •••••@•••••
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NCH Baker Hospital-Naples Heart Institute
NOT_YET_RECRUITINGNaples, Florida, 34102, United States
Contact Phone: •••-•••-••••
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Ohio Health Research Institute (aka Riverside Methodist Hospital)
NOT_YET_RECRUITINGColumbus, Ohio, 43214, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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St Andrews War Memorial Hospital
NOT_YET_RECRUITINGSpring Hill, Queensland, 4000, Australia
Contact
Contact Email: •••••@•••••
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St. Lukes Hospital Of Kansas City
RECRUITINGKansas City, Missouri, 64111, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Email: •••••@•••••
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St. Vincent Hospital
RECRUITINGIndianappolis, Indiana, 46260, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of Virginia Medical Center
NOT_YET_RECRUITINGCharlottesville, Virginia, 22903, United States
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart valve mystery: scientists hunt for genetic clues in 1,000 patients
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