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

NCT04704258 | Completed DMC

• 1 other identifier: #2020-01 (EU)
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

TAVI; Transcatheter Anti-embolic Filter; Cerebral Embolic Protection; Embolic Protection Device; Debris; Embolic material

Outcome Measures

Primary Outcomes (2)

• FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events

  Primary Safety Endpoint: FLOWer device Safety, rate of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. MACCEs are based on the Valve Academic Research Consortium (VARC- 3) criteria: * all death; * all stroke (disabling and non-disabling); * acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first)

  30 days

• Reduction in total volume of new cerebral lesions in all territories at serial DWMRI

  Primary Clinical Benefit Endpoint: Reduction in total volume of new cerebral lesions in all territories at serial DWMRI, compared to historical data in control arm (unprotected) data from previous randomized studies

  Within 2-5 days after procedure vs. baseline

Secondary Outcomes (6)

• Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee.

  7 and 30 days

• Brain imaging (DW-MRI)

  Within 2-5 days after procedure vs. baseline

• Neurocognitive

  2-7 days and 30-days vs. baseline

• Technical Success

  Immediately after procedure

• Debris capture

  Immediately after procedure

Study Arms (1)

TAVI + Embolic protection

EXPERIMENTAL

Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI

Procedure: TAVI (Transcatheter Aortic Valve Implant); Device: FLOWer Embolic Protection System

Interventions

TAVI (Transcatheter Aortic Valve Implant) PROCEDURE

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

TAVI + Embolic protection

FLOWer Embolic Protection System DEVICE

FLOWer Embolic Protection System

Also known as: transcatheter embolic protection for TAVI procedures

TAVI + Embolic protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age ≥ 18 years
• Subject is scheduled to undergo transfemoral aortic valve implant (TAVI) procedure on a stenotic native aortic valve and is qualified based on pre-operative CT-scan examination (trans-thoracic echocardiogram (TTE) can be used as confirmatory assessment)
• Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size
• The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits
• The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB)

You may not qualify if:

• Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin
• Subjects with contraindication to cerebral MRI
• Subjects with a history of a stroke or transient ischemic attack within the prior 6 months
• Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure
• Renal insufficiency (creatinine \> 3.0 mg/dL or Glomerular Filtration Rate GFR \< 30) and/or renal replacement therapy at the time of screening
• Subjects with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months
• Subjects with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
• Subject is currently participating in another drug or device clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation
• Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI)
• Subject requires an emergent procedure
• Subject has active major psychiatric disease
• Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• Subject has an ejection fraction of 30% or less
• Subjects with active endocarditis or other systemic infection
• Subjects undergoing therapeutic thrombolysis

Sponsors & Collaborators

• AorticLab Srl: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (8)

HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim

Antwerp, 2020, Belgium

Location

CUB Hôpital Erasme (ULB)

Brussels, 1070, Belgium

Location

Casa di Cura Policlinico di Monza

Monza, MB, 20900, Italy

Location

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

San Carlo Azienda Ospedaliera Regionale

Potenza, PZ, 85100, Italy

Location

Centro Cardiologico Monzino IRCCS

Milan, 20138, Italy

Location

Clinica San Gaudenzio

Novara, 28100, Italy

Location

Related Links

• Aorticlab Sponsor website
• Meditrial Clinical Research Organization

MeSH Terms

Conditions

Aortic Valve Stenosis; Intracranial Embolism and Thrombosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Franco Osta

  AorticLab Srl

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 11, 2021
• Study Start: May 3, 2021
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

BE (2); IT (6)