Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation * A Randomized Diffusion-Weighted MRI Study (CP-11134)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

1. Contraindications to TAVI per heart team
2. Current or recent cerebrovascular accident (stroke, TIA) <6 months
3. Transapical, direct aortic or subclavian TAVI access
4. Carotid stenting or endarterectomy in last 6 weeks
5. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant Carotid Endarterectomy / stenting
6. History of atrial fibrillation (AF) including:
o Persistent AF (defined as continuous AF which is sustained beyond seven days, or lasting greater than 48 hours and less than seven days but necessitating pharmacologic or electrical cardioversion), or
o History of Paroxysmal AF during the previous 30 days. Paroxysmal AF is defined as recurrent AF (>2 episodes) that terminates spontaneously within 7 days. Episodes of AF of < 48 hours* duration that are terminated with electrical or pharmacologic cardioversion are also classified as paroxysmal AF episodes.;7. Subject with active endocarditis or other systemic infection
8. Prior aortic valve replacement
9. Concomitant procedure with TAVI such as CABG, PCI, etc.
10. Claustrophobia
11. Contraindications to MRI (subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure). Planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator after TAVR
12. Allergy to intravascular contrast agents
13. Immobilization or other morbidity with life expectancy < 1 year
14. Inability to accommodate a 6F sheath (Sentinel) or 5F (LV1) into the right and left radial or brachial arteries respectively
15. Inadequate circulation to the right or left extremity as evidenced by signs of artery occlusion (modified Allen*s test) or absence of radial/brachial pulse
16. Subjects with vascular tortuosity or anatomy that would preclude the safe introduction and placement of the Sentinel System and/or the LV1 System per anatomy screening process
17. Lack of written informed consent
18. Patients in whom anticoagulant and antiplatelet therapy is contraindicated
19. Patients with uncorrected bleeding disorders
20. Patients with compromised blood flow to the left upper extremity
21.Patient who has arterial stenosis >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>Acute cerebral embolic burden reduction after TAVI assessed with 1.5-tesla<br /><br>DW-MRI at Day 2-4 compared to baseline </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>* MACCE @ 30 days<br /><br>* Histopathology (proximal, distal, LV1 Filter)<br /><br>* Neurological examinations, National Institutes of Health Stroke Scale (NIHSS)<br /><br>and Modified Rankin (mRS)<br /><br>* LV1 System Success<br /><br>Major Adverse Cardiac and Cerebrovascular Events (MACCE) is comprised of the<br /><br>following:<br /><br>* All-cause mortality<br /><br>* All stroke (major, minor, TIA)<br /><br>* Acute Kidney Injury (Class 3)</p><br>