Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

Inclusion criteria

• Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient > 40 mmHg; max velocity > 4m/s; aortic valve area ≤ 0.8 cm2.
• Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.
• Logistic EuroSCORE predicted risk for mortality of ≥20%, or comorbidity judged by the investigator to pose an absolute or relative contraindication for conventional aortic valve replacement.
• Patient is indicated for aortic valve implantation with a biological prosthesis (tissue valve) in accordance with the 2007 European Society of Cardiology (ESC) Guidelines for management of valvular heart disease.
• Age ≥ 18 years.
• Echocardiographically determined aortic annulus diameter of ≥19 mm and ≤ 26 mm in a long-axis view.

Exclusion criteria

• Congenital unicuspid or bicuspid aortic valve.
• Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in diameter.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Left ventricular ejection fraction < 25%, as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available
• Hypertrophic obstructive cardiomyopathy.
• Patients with life expectancy less than 12 months due to an underlying non-cardiac comorbid disease.
• Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol.
• Sepsis or acute endocarditis.
• Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
• Renal insufficiency assessed by creatinine > 2.5 mg/dl 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 aortic balloon valvuloplasty, 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.
• Mitral regurgitation greater than 2+ by angiography or moderate by echocardiography.
• Patient refuses a blood transfusion.
• Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.