Clinical trial NCT04704258: NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
Official title: Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Intracranial Embolism and Thrombosis
Keywords: TAVI
Transcatheter Anti-embolic Filter
Cerebral Embolic Protection
Embolic Protection Device
Debris
Embolic material
Lead sponsor: AorticLab Srl
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2021-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects of age ≥ 18 years
2. 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)
3. Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size
4. 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
5. 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)

1. Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin
2. Subjects with contraindication to cerebral MRI
3. Subjects with a history of a stroke or transient ischemic attack within the prior 6 months
4. Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure
5. Renal insufficiency (creatinine \> 3.0 mg/dL or Glomerular Filtration Rate GFR \< 30) and/or renal replacement therapy at the time of screening
6. 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
7. 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
8. 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
9. Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI)
10. Subject requires an emergent procedure
11. Subject has active major psychiatric disease
12. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
13. Subject has an ejection fraction of 30% or less
14. Subjects with active endocarditis or other systemic infection
15. Subjects undergoing therapeutic thrombolysis
16. Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test

Computerized Tomographic exclusion criteria (preoperative screening)

1. Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch
2. Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation
3. 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)
4. Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access
6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous

Primary outcomes:
measure: FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 30 days
measure: Reduction in total volume of new cerebral lesions in all territories at serial DWMRI
timeFrame: Within 2-5 days after procedure vs. baseline
Secondary outcomes:
measure: Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee.
timeFrame: 7 and 30 days
measure: Brain imaging (DW-MRI)
timeFrame: Within 2-5 days after procedure vs. baseline
measure: Neurocognitive
timeFrame: 2-7 days and 30-days vs. baseline
measure: Technical Success
timeFrame: Immediately after procedure
measure: Debris capture
timeFrame: Immediately after procedure
measure: FLOWer System Usability
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme (ULB)
city: Monza
country: Italy
facility: Casa di Cura Policlinico di Monza
state: MB
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
city: Potenza
country: Italy
facility: San Carlo Azienda Ospedaliera Regionale
state: PZ
city: Milano
country: Italy
facility: Centro Cardiologico Monzino IRCCS
city: Novara
country: Italy
facility: Clinica San Gaudenzio
Study officials:
affiliation: AorticLab Srl
name: Franco Osta
role: STUDY_CHAIR
References: