Engager Direct Aortic Clinical Study

Inclusion Criteria

• Severe aortic stenosis as defined by Doppler echocardiography: aortic valve area ≤ 0.8 cm2 (or AVA index ≤ 0.5 cm2/m2), or mean gradient ≥ 40 mmHg, or max velocity ≥ 4m/s
• NYHA Functional Class II or greater;
• Logistic EuroSCORE I ≥ 20%, or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement;
• Non-calcified ascending aortic site ≥ 50 mm from the aortic valve basal plane;
• Age ≥ 18 years;
• The patient has been informed of the nature of the study and has consented to participate, authorizing the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form"). Patient should understand the implications of participating in the study and should be legally competent to provide informed consent.

Exclusion Criteria

• Unicuspid or bicuspid aortic valve;
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
• Left ventricular ejection fraction < 25%;
• Left ventricular outflow obstruction, such as Hypertrophic Obstructive Cardiomyopathy and severe septal hypertrophy;
• Mitral or tricuspid regurgitation greater than 2+ by angiography or moderate by echocardiography;
• Patients with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease;
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol or contrast medium that cannot be adequately controlled with pre-medication;
• Sepsis or acute endocarditis;
• Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy;
• Renal insufficiency assessed by creatinine clearance < 20 ml/min and/or end-stage renal disease requiring chronic dialysis;
• Active peptic ulcer or GI bleeding within 3 months from the planned index procedure;
• Untreated clinically significant coronary artery disease requiring revascularization;
• Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance;
• Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater;
• Need for emergency surgery, cardiac or non-cardiac;
• History of myocardial infarction in the last 6 weeks;
• History of TIA or CVA in the last 6 months;
• Therapeutic invasive cardiac procedure, with the exception of BAV, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents;
• Pre-existing prosthetic heart valve or prosthetic ring in any position;
• Patent RIMA or pre-existing patent RIMA graft at direct aortic access site and/or trajectory;
• Patient refuses a blood transfusion;
• Pregnant or breastfeeding women;
• Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.