severe headache
Conditions
Interventions
The LV1 System (investigational product) provides additional cerebral
protection to unprotected regions of the brain. This product is similar to the
Sentinel System, but is intended to be placed int
Sponsors
Claret Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Severe symptomatic aortic valve stenosis 2. Compatible anatomy for Sentinel and LV1 Systems: o Sentinel System: left common carotid artery (6.5 * 10 mm) and brachiocephalic artery (9 * 15 mm) diameters o LV1 System: left subclavian artery (7.0 * 12.0 mm) diameter 3. Subject eligible for transfemoral TAVI access with planned implantation of Boston Scientific Lotus Valve System
Exclusion criteria
Exclusion criteria: 1. Contraindications to TAVI per heart team 2. Current or recent cerebrovascular accident (stroke, TIA) 2 episodes) that terminates spontaneously within 7 days. Episodes of AF of 70% in the left subclavian artery 22.Patient whose left subclavian artery reveals significant stenosis, ectasia, dissection, or aneurysm between the aortic ostium and the left vertebral artery 23. Patient is pregnant or lactating 24. Patients requiring left axillary/subclavian access for transcatheter aortic valve implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Acute cerebral embolic burden reduction after TAVI assessed with 1.5-tesla DW-MRI at Day 2-4 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * MACCE @ 30 days * Histopathology (proximal, distal, LV1 Filter) * Neurological examinations, National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin (mRS) * LV1 System Success Major Adverse Cardiac and Cerebrovascular Events (MACCE) is comprised of the following: * All-cause mortality * All stroke (major, minor, TIA) * Acute Kidney Injury (Class 3) | — |
Countries
Netherlands
Outcome results
None listed