F2 Filter for Aortic Stenosis

(SHIELD Trial)

Recruiting at 5 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

Trial Summary

What is the purpose of this trial?

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)

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.

How is the F2 Filter treatment for aortic stenosis different from other treatments?

The F2 Filter and Delivery System is unique because it likely incorporates a filter for neuroprotection during transcatheter aortic valve implantation (TAVI), which may help reduce the risk of stroke by capturing debris that could travel to the brain during the procedure. This is an additional safety measure compared to traditional surgical or transcatheter valve replacements. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity-matched analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Filter neuroprotection of a single patent internal carotid artery during transapical aortic valve implantation. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Correlation between intracoronary physiology and myocardial perfusion imaging in patients with severe aortic stenosis. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of aortic valve stenosis]. [2021]