Trial Of The F2 Filter And Delivery System For Embolic Protection During TAVR

Overview

About this study

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)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/6/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mayra Guerrero

Contact us for the latest status

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available