Cerebral Protection in Transcatheter Aortic Valve Replacement
United States363 participantsStarted 2014-09
Plain-language summary
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Approved indications for commercially available Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria below:
✓. transfemoral delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction \>20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be:
✓. inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or
✓. be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score \>8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
✓. transapical delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction \> 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score 8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
✓. in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
✓. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality
What they're measuring
1
Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
Timeframe: Day 2-7 Post-Procedure
2
Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
✓. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visit
Exclusion criteria
✕. Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
✕. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
✕. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
✕. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
✕. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
✕. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+)
✕. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)
✕. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency