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

Key Inclusion Criteria

• Age ≥ 21 and ≤ 90 years
• Patient meets the established criteria and indications for commercially available TAVR (e.g., balloon expandable SAPIEN valve platform, self-expanding CoreValve platform, or Navitor TAVI System) 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

Key Exclusion Criteria

General Exclusion Criteria

Participants are not eligible for the study if any of the following criteria are present:

General Exclusion Criteria

• Requires an urgent or emergent TAVR procedure.
• Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure (e.g., pacemaker placement, BAV, PCI) or planned within 30 days post-TAVR procedure.
• Current or planned participation in any investigational device/biopharma study during the duration of this study protocol.
• Diagnostic cardiac catheterization within 10 days prior to TAVR procedure (Note: unplanned diagnostic catheterization is allowed during TAVR procedure, but must be performed prior to insertion of the investigational device into the vasculature).
• Concomitant non-valvular intervention, vascular intervention, or leaflet modification is planned at time of TAVR procedure. (Note: balloon aortic valvuloplasty during TAVR procedure is permitted).
• 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.
• Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, nickel-titanium and/or contrast sensitivity that cannot be adequately pre-medicated.
• Presence or history of bleeding diathesis or coagulopathy.
• Contraindicated for anti-platelet and/or anticoagulant therapy.
• Refuses blood transfusion.
• Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the 3 months prior to TAVR procedure.
• Renal insufficiency (creatinine > 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
• Hepatic failure (Child-Pugh class C).
• Presenting with cardiogenic shock or requiring vasopressor or inotropic support, or with severe hypotension (systolic blood pressure \< 90 mm Hg) at the time of randomization.
• 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. Female participants of child-bearing potential must have a negative pregnancy test at screening.
• Any other condition that in the opinion of the investigator precludes study participation or poses a significant hazard to the patient.

Neurological Exclusion Criteria

• Modified Rankin Scale (mRS) ≥ 2 at screening.
• Cerebrovascular event including TIA within 6 months of the procedure.
• 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.
• Severe visual, auditory, or learning impairment.
• Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Note: use of general anesthesia during TAVR may affect neurocognitive function shortly after the procedure. While not an exclusion criterion, it is recommended that general anesthesia not be used, if possible.

Magnetic Resonance Imaging Exclusion Criteria:

• Body Mass Index (BMI) precluding imaging in scanner.
• 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 (e.g., patients with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
• 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 (e.g., thoracic endovascular aortic repair [TEVAR]/endovascular abdominal aortic aneurysm repair [EVAR], iliac/superficial femoral artery [SFA] stent).
• Access vessels with excessive tortuosity or complex anatomy that would likely necessitate a surgical cutdown approach (e.g., distance from skin to vessel is extensive).
• Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.
• Ascending aortic diameter less than 18 mm or greater than 38 mm measured 6 to 8 cm from the annulus.
• Transverse aortic arch diameter less than 18 mm or greater than 27 mm when measured immediately proximal to the ostium of the left subclavian artery.