Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
NCT ID: NCT06689839
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2025-09-09
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Cerebral Protection System (CPS) (treatment group) or
* Transcatheter Aortic Valve Replacement (TF TAVR) with Standard of Care treatment (no embolic protection or use of the commercially available protection device, Sentinel System; control group)
TREATMENT
SINGLE
Study Groups
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F2 Filter and Delivery System
The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure
F2 Filter and Delivery System
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Either the Sentinel Cerebral Protection System or no embolic protection device
Either the Sentinel Cerebral Protection System or no embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure depending on the Standard of Care at the treating institution
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Interventions
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F2 Filter and Delivery System
Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Eligibility Criteria
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Inclusion Criteria
* Patient meets the established criteria and indications for commercially available TAVR 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.
* Patient is able and willing to provide written informed consent.
* Patient meets all criteria for use of control device (Sentinel device, per IFU).
Exclusion Criteria
* Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
* Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
* Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
* Prior prosthetic heart valve in any position.
* Known intracardiac thrombus.
* Active infection or endocarditis.
* Patient is contraindicated for anti-platelet and/or anticoagulant therapy.
* Patient refuses blood transfusion.
* Renal insufficiency (creatinine \> 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
* Patients with hepatic failure (Child-Pugh class C).
* Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30%.
* Females who are pregnant or nursing or plan to become pregnant during their participation in the study.
* Modified Rankin Scale (mRS) ≥ 2 at screening.
* Cerebrovascular event including TIA within 6 months of the procedure.
* Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
* Patient has severe visual, auditory, or learning impairment.
* Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
* Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
* High risk of complete AV block after TAVR, with the need of permanent pacemaker.
* Claustrophobia precluding MRI scanning.
* Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
* Presence of cardiovascular implant in aorta and/or peripheral access vessels.
* Access vessels with excessive tortuosity.
* Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.
50 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Insight Medical Consulting
UNKNOWN
EnCompass Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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NCH Baker Hospital-Naples Heart Institute
Naples, Florida, United States
St. Vincent Hospital
Indianappolis, Indiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Lukes Hospital Of Kansas City
Kansas City, Missouri, United States
Cumc/Nyph
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute (aka Riverside Methodist Hospital)
Columbus, Ohio, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
St Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
Monash Health Public
Clayton, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Kathy Byrd
Role: primary
Other Identifiers
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ET03
Identifier Type: -
Identifier Source: org_study_id
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