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NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device

NCT04704258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-23

No results posted yet for this study

Summary

The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic Valve Implant).

Conditions

  • Aortic Valve Stenosis
  • Intracranial Embolism and Thrombosis

Interventions

PROCEDURE

TAVI (Transcatheter Aortic Valve Implant)

Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures

DEVICE

FLOWer Embolic Protection System

FLOWer Embolic Protection System

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • AorticLab Srl

    lead INDUSTRY

Principal Investigators

  • Franco Osta · AorticLab Srl

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2023-06-06
Completion
2023-06-06

Countries

  • Belgium
  • Italy

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 NCT04704258 on ClinicalTrials.gov