Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

Clinical

Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure.

Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure

Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.

Untreated clinically significant coronary artery disease requiring revascularization.

Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.

Need for emergency surgery for any reason.

Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram.

Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

Active Gastrointestinal (GI) bleeding that would preclude anticoagulation.

A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including ability to be anticoagulated for the index procedure), nitinol, or \[allergic\] sensitivity to contrast media which cannot be adequately pre-medicated.

Ongoing sepsis, including active endocarditis.

Subject refuses a blood transfusion.

Life expectancy \<12 months due to associated non-cardiac co-morbid conditions.

Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.

Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).

Currently participating in an investigational drug or another device study.

Symptomatic carotid or vertebral artery disease.

Anatomical

Subject has a:

Native aortic annulus size \<18 mm or \>29 mm per the baseline diagnostic imaging (not applicable for TAV in SAV subjects) OR

Surgical bioprosthetic annulus \<17mm or \>29mm i. Stented SAV per the manufactured labeled inner diameter OR ii. Stentless SAV per the baseline diagnostic imaging

Subject has a pre-existing prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position:

1. that could affect the implantation or function of the study valve OR

2. the implantation of the study valve could affect the function of the pre-existing prosthetic heart valve

Moderate to severe mitral stenosis.

Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed surgical bioprothesis)

Hypertrophic obstructive cardiomyopathy.

Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation.

Severe basal septal hypertrophy with an outflow gradient.

Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \>70° (for femoral and left subclavian/axillary access) and \>30° (for right subclavian/axillary access).

Ascending aorta that exceeds the maximum diameter for any given native or surgical bioprosthetic\* aortic annulus size (see table below) Aortic Annulus Diameter/ Ascending Aorta Diameter, 18 mm\* - 20 mm/ \>34 mm, 20 mm - 23 mm/ \>40 mm, 23 mm - 27 mm/ \>43 mm, 27 mm - 29 mm/ \>43 mm,

\* 17mm for surgical bioprosthetic aortic annulus

Congenital bicuspid or unicuspid valve verified by echocardiography (Not applicable for TAV in SAV subjects).

Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Degenerated surgical bioprothesis presents with a significant concomitant perivalvular leak (between prothesis and native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in SAV subjects)

Degenerated surgical bioprothesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects)

Vascular

Transarterial access not able to accommodate an 18Fr sheath.

What this study is about