NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device (NAUTILUS)
Primary Purpose
Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TAVI (Transcatheter Aortic Valve Implant)
FLOWer Embolic Protection System
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Stenosis focused on measuring TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
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
- 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 < 29 and > 34 mm at baseline CT (measured between 1 and 10 mm upstream 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 sheath vascular access
- Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous
Sites / Locations
- HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) MiddelheimRecruiting
- CUB Hôpital Erasme (ULB)Recruiting
- Casa di Cura Policlinico di MonzaRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- IRCCS Policlinico San DonatoRecruiting
- San Carlo Azienda Ospedaliera RegionaleRecruiting
- Centro Cardiologico Monzino IRCCSRecruiting
- Clinica San GaudenzioRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAVI + Embolic protection
Arm Description
Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI
Outcomes
Primary Outcome Measures
FLOWer System Safety, rate of Major Adverse Cardiac and Cerebrovascular Events
related to FLOWer Device or 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), and acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first).
Cumulative occurrence of Serious Clinical Events related to device or procedure
death, stroke, bleeding, AKI, and procedural complications
Secondary Outcome Measures
Technical Success
defined as successful placement, insertion and removal of the FLOWer System
Debris capture
by the FLOWer System with gross and histopathological evaluation including particle size and composition
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
Full Information
NCT ID
NCT04704258
First Posted
January 4, 2021
Last Updated
February 7, 2023
Sponsor
AorticLab Srl
Collaborators
Meditrial Europe Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04704258
Brief Title
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
Acronym
NAUTILUS
Official Title
Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AorticLab Srl
Collaborators
Meditrial Europe Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
Keywords
TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAVI + Embolic protection
Arm Type
Experimental
Arm Description
Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI
Intervention Type
Procedure
Intervention Name(s)
TAVI (Transcatheter Aortic Valve Implant)
Intervention Description
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
Intervention Type
Device
Intervention Name(s)
FLOWer Embolic Protection System
Other Intervention Name(s)
transcatheter embolic protection for TAVI procedures
Intervention Description
FLOWer Embolic Protection System
Primary Outcome Measure Information:
Title
FLOWer System Safety, rate of Major Adverse Cardiac and Cerebrovascular Events
Description
related to FLOWer Device or 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), and acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first).
Time Frame
7 and 30 days
Title
Cumulative occurrence of Serious Clinical Events related to device or procedure
Description
death, stroke, bleeding, AKI, and procedural complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical Success
Description
defined as successful placement, insertion and removal of the FLOWer System
Time Frame
immediately after procedure
Title
Debris capture
Description
by the FLOWer System with gross and histopathological evaluation including particle size and composition
Time Frame
immediately after procedure
Title
FLOWer System Usability
Description
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
Time Frame
immediately after procedure
Other Pre-specified Outcome Measures:
Title
Brain imaging (DW-MRI)
Description
Reduction in the total volume of new cerebral lesions in all territories at serial DW-MRI, compared to historical data in the control arm (unprotected)
Time Frame
procedure vs. baseline
Title
Neurocognitive
Description
Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS
Time Frame
2-7 days and 30-days vs. baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Pasquino
Phone
+41795388214
Email
enrico.pasquino@aorticlab.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Tocchi, MD
Email
m.tocchi@meditrial.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Osta
Organizational Affiliation
AorticLab Srl
Official's Role
Study Chair
Facility Information:
Facility Name
HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierfrancesco Agostoni, MD
First Name & Middle Initial & Last Name & Degree
Pierfrancesco Agostoni, MD
Facility Name
CUB Hôpital Erasme (ULB)
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvin Kedhi, MD
Email
ekedhi@me.com
First Name & Middle Initial & Last Name & Degree
Elvin Kedhi, MD
Facility Name
Casa di Cura Policlinico di Monza
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Scalise
Email
filippo.scalise@policlinicodimonza.it
First Name & Middle Initial & Last Name & Degree
Filippo Scalise
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Montorfano
Email
montorfano.matteo@hsr.it
First Name & Middle Initial & Last Name & Degree
Matteo Montorfano
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nedy Brambilla
Email
nedybrambilla@gmail.com
First Name & Middle Initial & Last Name & Degree
Nedy Brambilla
Facility Name
San Carlo Azienda Ospedaliera Regionale
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Stabile, MD
Email
geko50@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eugenio Stabile, MD
Facility Name
Centro Cardiologico Monzino IRCCS
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico De Marco, MD
Email
federico.demarco@gmail.com
First Name & Middle Initial & Last Name & Degree
Federico De Marco, MD
Facility Name
Clinica San Gaudenzio
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Sorropago, MD
Email
giovannisorropago@gmail.com
First Name & Middle Initial & Last Name & Degree
Giovanni Sorropago, MD
12. IPD Sharing Statement
Links:
URL
http://www.aorticlab.ch
Description
Aorticlab Sponsor website
URL
http://www.meditrial.net
Description
Meditrial Clinical Research Organization
Learn more about this trial
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
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