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

NCT05893082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-17

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 undergoing 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 the great cerebral vessels.

Sponsors & Collaborators

  • EnCompass Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Francis Duhay, MD · Sponsor GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Device
Yes

Countries

  • Australia

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 NCT05893082 on ClinicalTrials.gov