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Device

F2 Filter for Aortic Stenosis (SHIELD Trial)

N/A

Waitlist Available

Research Sponsored by EnCompass Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patient requires an urgent or emergent TAVR procedure

Active infection or endocarditis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-72 hours post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare a new device called the F2 Cerebral Protection System to the current standard of care for patients getting Transcatheter Aortic Valve Replacement (TF TAVR)

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, potential risks may include bleeding due to device insertion, allergic reactions to materials in the filter or delivery system, stroke if debris bypasses the filter, and vascular complications at access sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need an urgent heart valve replacement.

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I do not have an active infection or endocarditis.

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I cannot take blood thinners due to health reasons.

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My kidney function is low or I am on dialysis.

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I have severe liver disease.

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I have a severe problem with my vision, hearing, or learning.

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I have a progressive neurological condition or significant past head injury with lasting effects.

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I do not have any implants or metal that would make an MRI unsafe for me.

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I am at high risk of a severe heart block after valve replacement, needing a permanent pacemaker.

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I have severe artery disease that affects procedures involving blood vessels.

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My aortic arch is heavily calcified or very twisted.

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I refuse to receive blood transfusions.

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I am not pregnant, nursing, nor planning to become pregnant during the study.

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My heart's pumping ability is significantly reduced.

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I have not had a stroke or mini-stroke in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-72 hours post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-72 hours post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-72 hours post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Total New Lesion Volume

Secondary study objectives

Stroke

Other study objectives

Average Lesion Size

Freedom from Lesions

Hospital Readmissions

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: F2 Filter and Delivery SystemExperimental Treatment2 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 deviceActive Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcatheter Aortic Valve Replacement (TAVR)

2019

N/A

~120

0 / 17Eligibility criteria met