NCT04704258: NAUTILUS

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

Completed NA Last updated 23 February 2024

What this trial tests

NA trial testing TAVI (Transcatheter Aortic Valve Implant) in Aortic Valve Stenosis in 100 participants. Completed in 6 June 2023.

Timeline

3 May 2021

Primary endpoint
6 June 2023

6 June 2023

Quick facts

Lead sponsor	AorticLab Srl
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	100
Start date	3 May 2021
Primary completion	6 June 2023
Estimated completion	6 June 2023
Sites	8 locations across Belgium, Italy

Drugs / interventions tested

• TAVI (Transcatheter Aortic Valve Implant)
• FLOWer Embolic Protection System

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
• Intracranial Embolism and Thrombosis — all drugs for Intracranial Embolism and Thrombosis →

Sponsor

AorticLab Srl

Who can join

18 and older, any sex, with Aortic Valve Stenosis or Intracranial Embolism and Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cerebral embolic protection during transcatheter heart interventions.
   Jimenez Diaz VA, Kapadia SR, Linke A, Mylotte D, et al · · 2023 · cited 23× · PMID 37720969 · DOI 10.4244/eij-d-23-00166
2. Cerebrovascular events after transcatheter aortic valve implantation.
   Reddy P, Merdler I, Ben-Dor I, Satler LF, et al · · 2024 · cited 10× · PMID 38949240 · DOI 10.4244/eij-d-23-01087
3. Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?
   Sayah N, Skalidis I, Mesnier J, Neylon A, et al · · 2024 · cited 4× · PMID 39336957 · DOI 10.3390/jcm13185471
4. Embolic Protection Devices in Transcatheter Aortic Valve Implantation: A Narrative Review of Current Evidence.
   Latsios G, Ktenopoulos N, Apostolos A, Koliastasis L, et al · · 2025 · cited 1× · PMID 40565846 · DOI 10.3390/jcm14124098
5. Calcium Load in the Aortic Valve, Aortic Root, and Left Ventricular Outflow Tract and the Risk for a Periprocedural Stroke.
   Bjursten H, Koul S, Duvernoy O, Fagman E, et al · · 2022 · cited 1× · PMID 37288334 · DOI 10.1016/j.shj.2022.100070
6. Assessment of the Safety and Effectiveness of the FLOWer Antiembolic Filter Supporting Transcatheter Aortic Valve Implantation.
   Sorropago A, De Marco F, Toscano E, Brambilla N, et al · · 2026 · PMID 41709490 · DOI 10.1002/ccd.70524
7. Insights into calcific aortic valve stenosis: a comprehensive overview of the disease and advancing treatment strategies
   Jain H, Goyal A, Khan A, Khan N, et al · · 2024