An interventional study of TAVI (Transcatheter Aortic Valve Implant) and FLOWer Embolic Protection System in Aortic Valve Stenosis and Intracranial Embolism and Thrombosis, sponsored by AorticLab Srl. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by AorticLab Srl · Not applicable, Interventional, and Other
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).
A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.
29 studies on the registry are indexed under Intracranial Embolism; none are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 18 interventional studies indexed under Intracranial Embolism.
Browse Intracranial Embolism studies →This is the only study on the registry with AorticLab Srl as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical exclusion criteria (preoperative screening)
Computerized Tomographic exclusion criteria (preoperative screening)
Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI
Procedure: TAVI (Transcatheter Aortic Valve Implant) · Device: FLOWer Embolic Protection System
Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
FLOWer Embolic Protection System
Also known as: transcatheter embolic protection for TAVI procedures
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)
Time frame: 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
Time frame: Within 2-5 days after procedure vs. baseline
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).
Time frame: 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
Time frame: Within 2-5 days after procedure vs. baseline
Neurocognitive
Secondary Clinical Benefit Endpoints: Neurocognitive protection assessed by NIHSS, Montreal Cognitive Assessment, and mRS
Time frame: 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
Time frame: Immediately after procedure
Debris capture
Secondary Performance Endpoints: Debris captured by the FLOWer System with gross and histopathological evaluation including particle size and composition
Time frame: 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
Time frame: Immediately after procedure
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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