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RECRUITINGINTERVENTIONAL

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Key Who May Qualify: - Age ≥ 50 years. - 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 willing to sign a consent form. - Patient meets all criteria for use of control device (Sentinel device, per IFU). Key Who Should NOT Join This Trial: General Who Should NOT Join This Trial: - Patient requires an urgent or emergent TAVR procedure. - 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. Neurological Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * Age ≥ 50 years. * 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). Key Exclusion Criteria: General Exclusion Criteria: * Patient requires an urgent or emergent TAVR procedure. * 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. Neurological Exclusion Criteria: * 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. Magnetic Resonance Imaging Exclusion Criteria: * 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. Anatomical and CT Exclusion Criteria: * 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.

Treatments Being Tested

DEVICE

F2 Filter and Delivery System

Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Locations (10)

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