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

Aortic Valve Stenosis Clinical Trial

— NAUTILUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704258
• Other study ID #: #2020-01 (EU)
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: June 6, 2023

Study information

• Verified date: February 2024
• Source: AorticLab Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Embolism
• Embolism and Thrombosis
• Intracranial Embolism
• Intracranial Embolism and Thrombosis
• Thrombosis

Intervention

Procedure:
• TAVI (Transcatheter Aortic Valve Implant)
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures

Device:
• FLOWer Embolic Protection System
FLOWer Embolic Protection System

Locations

Country	Name	City	State
Belgium	HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim	Antwerp
Belgium	CUB Hôpital Erasme (ULB)	Brussels
Italy	IRCCS Ospedale San Raffaele	Milan	MI
Italy	Centro Cardiologico Monzino IRCCS	Milano
Italy	Casa di Cura Policlinico di Monza	Monza	MB
Italy	Clinica San Gaudenzio	Novara
Italy	San Carlo Azienda Ospedaliera Regionale	Potenza	PZ
Italy	IRCCS Policlinico San Donato	San Donato Milanese	MI

Sponsors (2)

Lead Sponsor	Collaborator
AorticLab Srl	Meditrial Europe Ltd.

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	7 and 30 days
Secondary	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	Within 2-5 days after procedure vs. baseline
Secondary	Neurocognitive	Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS	2-7 days and 30-days vs. baseline
Secondary	Technical Success	Secondary Performance Endpoints: Technical Success defined as successful placement, insertion and removal of the FLOWer System	Immediately after procedure
Secondary	Debris capture	Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition	Immediately after procedure
Secondary	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	Immediately after procedure

External Links

•   Aorticlab Sponsor website
•   Meditrial Clinical Research Organization