Aortic Valve StenosisNAUTILUSNCT04704258

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

A study testing TAVI (Transcatheter Aortic Valve Implant) and FLOWer Embolic Protection System in people with Aortic Valve Stenosis and Intracranial Embolism and Thrombosis, run by AorticLab Srl at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
What is being tested?: TAVI (Transcatheter Aortic Valve Implant) and FLOWer Embolic Protection System
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 8 sitesin 2 countries
Study dates: 3 May 2021to 6 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

Clinical exclusion criteria (preoperative screening)
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

Show all 24Show fewer

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
Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test
Computerized Tomographic exclusion criteria (preoperative screening)
Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch
Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation
Subjects with a diameter of the ascending aorta < 25 and > 39 mm at baseline CT (measured 10 mm upstream of the first vessel of the brachiocephalic trunk)
Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access
Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Italy6 sites

IRCCS Ospedale San Raffaele
Milan, MI, 20132
Centro Cardiologico Monzino IRCCS
Milan, 20138
Casa di Cura Policlinico di Monza
Monza, MB, 20900
Clinica San Gaudenzio
Novara, 28100
San Carlo Azienda Ospedaliera Regionale
Potenza, PZ, 85100
IRCCS Policlinico San Donato
San Donato Milanese, MI, 20097

Other trials in Italy

Belgium2 sites

HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Antwerp, 2020
CUB Hôpital Erasme (ULB)
Brussels, 1070

Other trials in Belgium

About this study

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

Read the 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
Being tested: TAVI (Transcatheter Aortic Valve Implant), FLOWer Embolic Protection System
Keywords: TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material
Medical subject headings: Aortic Valve Stenosis, Intracranial Embolism and Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAVI (Transcatheter Aortic Valve Implant)Procedure or surgery
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
FLOWer Embolic Protection SystemDevice
Also called transcatheter embolic protection for TAVI procedures
FLOWer Embolic Protection System

Study groups in NCT04704258
Study group	Role	What they receive
TAVI + Embolic protection	Experimental	Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI Receives: Procedure: TAVI (Transcatheter Aortic Valve Implant); Device: FLOWer Embolic Protection System

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Measured: 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.
Secondary Safety Endpoint: Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. all-cause mortality including cardiovascular mortality;
- all stroke (disabling and non-disabling);
- bleeding (life-threatening or disabling);
- acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first);
- major device access related vascular complications;
- coronary artery obstruction requiring intervention;
- valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, repeat TAVI, or surgical aortic valve replacement).
Measured: 7 and 30 days
Brain imaging (DW-MRI)
Secondary Clinical Benefit Endpoints: Acute cerebral embolic burden reduction after TAVI, defined as number and volume of new cerebral lesions in all cerebral territories assessed by DW-MRI
Measured: Within 2-5 days after procedure vs. baseline
Neurocognitive
Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS
Measured: 2-7 days and 30-days vs. baseline
Technical Success
Secondary Performance Endpoints: Technical Success defined as successful placement, insertion and removal of the FLOWer System
Measured: Immediately after procedure
Debris capture
Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition
Measured: Immediately after procedure
FLOWer System Usability
Secondary Performance Endpoints: FLOWer System Usability graded by the Investigator with a 5-point Likert scale
The minimum and the maximum values of the scale are defined as follows:
(1) Unacceptable; (2) Poor; (3) Acceptable; (4) Good; (5) Excellent
Measured: Immediately after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 20216 Jun 2023

First posted11 Jan 2021
Study start3 May 2021
Primary completion6 Jun 2023
Study completion6 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04704258
Sponsor's protocol ID: #2020-01 (EU)
Acronym: NAUTILUS
Status last verified: Feb 2024
First submitted: 4 Jan 2021
Last updated: 23 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions
ClinicalTrials.gov ID: NCT04704258
Acronym / sponsor ID: NAUTILUS / #2020-01 (EU)
Conditions: Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
Keywords: TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AorticLab SrlIndustry (pharma, biotech, devices)
Collaborators: Meditrial Europe Ltd.
Study start: 3 May 2021 (actual)
Primary completion: 6 Jun 2023 (actual)
Study completion: 6 Jun 2023 (actual)
First posted: 11 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAVI + Embolic protection	Experimental	Procedure: TAVI (Transcatheter Aortic Valve Implant), Device: FLOWer Embolic Protection SystemSubjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (24 listed)

Clinical exclusion criteria (preoperative screening)
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAVI (Transcatheter Aortic Valve Implant)Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures	Procedure or surgery	TAVI + Embolic protection
FLOWer Embolic Protection SystemAlso: transcatheter embolic protection for TAVI proceduresFLOWer Embolic Protection System	Device	TAVI + Embolic protection

Primary outcome

FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events
Time frame: 30 days
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)
Reduction in total volume of new cerebral lesions in all territories at serial DWMRI
Time frame: Within 2-5 days after procedure vs. baseline
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

6 secondary outcomes

Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee.
Time frame: 7 and 30 days
Brain imaging (DW-MRI)
Time frame: Within 2-5 days after procedure vs. baseline
Neurocognitive
Time frame: 2-7 days and 30-days vs. baseline
Technical Success
Time frame: Immediately after procedure
Debris capture
Time frame: Immediately after procedure
FLOWer System Usability
Time frame: Immediately after procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Aorticlab Sponsor websiteLink provided by the sponsor.
Meditrial Clinical Research OrganizationLink provided by the sponsor.

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Franco Osta study chair

AorticLab Srl

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04704258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.