NCT04704258

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

Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AorticLab Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.

Conditions

• Aortic Valve Stenosis
• Intracranial Embolism and Thrombosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-03
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2021-01-11
• Last updated: 2024-02-23

Locations

8 sites across 2 countries: Belgium, Italy