F2 Filter for Aortic Stenosis

(SHIELD Trial)

Recruiting at 11 trial locations

Overseen By Kathleen S Calderon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: EnCompass Technologies, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Renal insufficiency, Hepatic failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: During procedure

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the F2 Filter, used during a Transcatheter Aortic Valve Replacement (TAVR) procedure. Researchers aim to determine if this filter is safer and more effective than the current standard, which sometimes involves another device or no device at all. The trial seeks participants scheduled for a TAVR procedure who can adhere to the study's guidelines. Interested individuals should not have had recent heart procedures or health issues such as severe kidney problems or infections.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance future TAVR procedures.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are contraindicated for anti-platelet or anticoagulant therapy, you may not be eligible to participate.

What prior data suggests that the F2 Filter and Delivery System is safe for use during Transcatheter Aortic Valve Replacement?

Research shows that the F2 Filter and Delivery System is undergoing safety testing during a heart valve procedure called TAVR. Earlier studies examined the F2 Filter's effectiveness in protecting the brain from tiny blood clots during this procedure. These studies found that using the F2 Filter was feasible and provided protection without major side effects.

Testing continues to ensure the F2 Filter's safety matches that of standard devices. Although it is not yet approved for general use, these findings help build confidence in its safety. Prospective trial participants may find this information reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the F2 Filter and Delivery System for aortic stenosis because it offers a new way to protect the brain during the Transcatheter Aortic Valve Replacement (TAVR) procedure. Unlike the standard Sentinel Cerebral Protection System, or cases where no embolic protection is used, the F2 Filter is designed to specifically capture and remove debris that could potentially cause a stroke. This novel mechanism of action represents a significant advancement in providing better cerebral protection, potentially reducing the risk of complications and improving patient outcomes during TAVR.

What evidence suggests that the F2 Filter and Delivery System is effective for aortic stenosis?

In earlier studies, the F2 Cerebral Protection System (CPS) showed promise during Transcatheter Aortic Valve Replacement (TAVR) procedures. Research indicates that the F2 filter can safely and effectively protect the brain by capturing debris that might otherwise travel there during the procedure. The filter covers three blood vessels simultaneously, ensuring thorough protection. Initial findings suggest that using the F2 filter is both safe and practical for this purpose. This trial will compare the F2 Filter and Delivery System with either the Sentinel Cerebral Protection System or no embolic protection device, depending on the Standard of Care at the treating institution. This approach could potentially lower the risk of stroke and other complications during TAVR. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with aortic stenosis, a condition where the heart's aortic valve narrows. Participants should be scheduled for Transcatheter Aortic Valve Replacement (TAVR), a procedure to replace the narrowed valve. Specific eligibility criteria are not provided but typically include age, health status, and absence of conditions that could complicate surgery.

Inclusion Criteria

Patient meets all criteria for use of control device (Sentinel device, per IFU)

Patient is willing and able to comply with protocol-specified follow-up evaluations

I am approved for and scheduled to undergo a heart valve replacement through my leg.

Exclusion Criteria

Access vessels with excessive tortuosity

Known intracardiac thrombus

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TF TAVR) with either the F2 Cerebral Protection System or standard of care

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of MACCE, lesion volume, and neurological outcomes

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• F2 Filter and Delivery System

Trial Overview The study tests the F2 Cerebral Protection System (CPS) against standard care during TAVR. The F2 CPS aims to protect the brain from embolic material—debris that might break loose during valve replacement and cause complications like stroke.

How Is the Trial Designed?

Group I: F2 Filter and Delivery System Experimental Treatment 2 Interventions

The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure

Group II: Either the Sentinel Cerebral Protection System or no embolic protection device Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

EnCompass Technologies, Inc.

Lead Sponsor

Trials

4

Recruited

530+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Insight Medical

Collaborator

Trials

1

Recruited

500+

Insight Medical Consulting

Collaborator

Trials

1

Recruited

500+

Citations

1. jscai.org jscai.org/article/S2772-9303(25)01050-6/fulltext

First-in-Human Experience With the EnCompass F2 Filter ... In this FIH series, cerebral embolic protection with the EnCompass F2 filter during transfemoral TAVR was demonstrated to be feasible and safe.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06689839

NCT06689839 | Trial of the F2 Filter and Delivery System ... The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and ...

3. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.103768

A Novel Approach for Cerebral Embolic Protection With ... The use of the novel EnCompass F 2 filter was feasible to provide complete cerebral embolic protection in TAVR using a single access.

4. cardiovascularbusiness.com cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/closer-look-worlds-first-tavr-patient-treated-new-cerebral-embolic-protection-device

A closer look at world's first TAVR patient treated with new ... A new cerebral embolic protection device (CEPD) that covers three vessels at once is safe to use during transcatheter aortic valve ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925005467

A Novel Approach for Cerebral Embolic Protection With ... This is the first published report of the use of the novel EnCompass F 2 filter, which consists of a cylindrical nitinol frame and electrospun filter.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05866640

Feasibility Trial of the F2 Filter and Delivery System for ... The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37520135/

Fractional Flow Reserve to Assess Coronary Artery ... The objectives of this study were to describe (1) the long-term outcomes based on the coronary artery disease (CAD) assessment strategy used and ...