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F2 Filter and Delivery System for Aortic Stenosis During TAVR

This study is testing a device called the F2 Filter and Delivery System during a procedure called Transcatheter Aortic Valve Replacement (TAVR). TAVR is used to treat aortic stenosis, a condition where the heart's aortic valve is narrowed. The goal is to see if the F2 Filter and Delivery System is as safe as current standard care and more effective at preventing new brain lesions. You may be able to join if you are at least 50 years old, need a TAVR procedure through your leg (transfemoral access), and are willing to follow the study plan. The study aims to enroll 500 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 500 participants. It compares the F2 Filter and Delivery System to a standard TAVR procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for Major Adverse Cardiac and Cerebrovascular Events (MACCE) for 30 days after the procedure, and for new brain lesions between 8 and 72 hours after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06689839

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

Recruiting
NAAges 50+InterventionalTreatment
EnCompass Technologies, Inc.
~500 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:F2 Filter and Delivery SystemTranscatheter Aortic Valve Replacement (TAVR)

At a glance

Recruiting sites
6 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Measured over 30 days post procedure
+1 more outcome measured

Conditions

Aortic Stenosis Treated With TAVI
Aortic Diseases

Explore related trials

Aortic Valve Stenosis

Where it's being run

10 sites across 9 states
Ohio2
Florida1
Indiana1
Michigan1
Missouri1
New York1
Virginia1
Queensland1

Who to contact

Kathleen S Calderon
[email protected]
3072502726
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.
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.

What this trial measures

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE)30 days post procedure

    MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3)

  • Total New Lesion Volume8-72 hours post procedure

    Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI)