Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01) (TA-FIM)

This is an interventional treatment trial for Aortic Stenosis Symptomatic focused on measuring Severe Symptomatic Aortic Valve Stenosis Read More

Inclusion Criteria:

• Patients older than 75 years;
• Additive EuroSCORE > 9 and/or STS > 9%;
• Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²;
• NYHA Functional Class > II;
• Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;
• Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography;
• Patient understands the implications of participating in the study and provides signed informed consent

Exclusion Criteria:

• Congenital unicuspid or bicuspid aortic valve;
• Severe eccentricity of calcification;
• Severe mitral regurgitation (> 2°);
• Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
• Severe transapical access problem, non-reachable LV apex;
• Previous surgery of the LV using a patch, such as the Dor procedure;
• Presence of apical LV thrombus;
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
• Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;
• PCI within 1 month prior to the procedure;
• Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;
• Untreated clinically significant CAD requiring revascularization;
• Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;
• Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) < 25% by echocardiography;
• Calcified pericardium;
• Septal hypertrophy;
• Primary Hypertrophic Obstructive Cardiomyopathy (HOCM);
• Active infection, endocarditis or pyrexia;
• Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months;
• Significant hepatic involvement (Child > B);
• Major lung disease (FEV < 0.8 or FEV1% < 30% of normal);
• Pulmonary hypertension;
• History of bleeding diathesis or coagulopathy;
• Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3);
• Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;
• Neurological disease severely affecting ambulation or daily functioning, including dementia;
• Other procedure scheduled at the same time, whether surgery or percutaneous approach;
• Emergency procedure;
• Life expectancy < 12 months due to non-cardiac co-morbid conditions;
• Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol;
• Currently participating in an investigational drug or another device study