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

NCT06689839 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-11-20

No results posted yet for this study

Summary

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)

Conditions

  • Aortic Stenosis Treated With TAVI
  • Aortic Diseases

Interventions

DEVICE

F2 Filter and Delivery System

Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Insight Medical Consulting

    collaborator UNKNOWN

  • EnCompass Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States
  • 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 NCT06689839 on ClinicalTrials.gov