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

NCT06069661 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

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 undergoing a Transcatheter Aortic Valve replacement procedure.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Aortic Stenosis

F2 Filter and Delivery system to cover the 3 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
2024-06-30
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

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 NCT06069661 on ClinicalTrials.gov