Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
Conditions
Keywords
TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material
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.
Interventions
PROCEDURETAVI (Transcatheter Aortic Valve Implant)
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
DEVICEFLOWer Embolic Protection System
FLOWer Embolic Protection System
Sponsors
Meditrial Europe Ltd.
AorticLab Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive | 2-7 days and 30-days vs. baseline | Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS |
| Technical Success | Immediately after procedure | Secondary Performance Endpoints: Technical Success defined as successful placement, insertion and removal of the FLOWer System |
| Cumulative occurrence of Serious Clinical Events related to FLOWer device and procedure as adjudicated by a Clinical Event Committee. | 7 and 30 days | 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). |
| FLOWer System Usability | Immediately after procedure | 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 |
| Debris capture | Immediately after procedure | Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition |
| Brain imaging (DW-MRI) | Within 2-5 days after procedure vs. baseline | 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 |
Countries
Belgium, Italy
Outcome results
None listed