Engager Direct Aortic Clinical Study
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve
 Implantation System via direct aortic approach.
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve
 Implantation System via direct aortic approach in patients with symptomatic severe aortic
 valve stenosis at high or extreme risk for surgical aortic valve replacement for which
 treatment via direct aortic access is preferred.
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.