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

NCT05866640 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-25

No results posted yet for this study

Summary

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 aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure.

Participants will complete several neurocognitive assessments and an MRI procedure.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

F2 filter and delivery system

Placement of F2 device in aorta to cover great cerebral vessels

Sponsors & Collaborators

  • EnCompass Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Francis Duhay, MD · Sponsor GmbH

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-29
Primary Completion
2025-12-30
Completion
2026-01-30
FDA Device
Yes

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05866640 on ClinicalTrials.gov