Clinical Research Directory

Inclusion Criteria: * I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years * I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient \< 40 mmHg and stroke volume index (SVI) \< 35ml/m2 * I3. Left ventricular ejection fraction ≥ 50% * I4. MDCT aortic valve calcium score men \> 2000AU, women \> 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age \< 70 yrs., AVS \< 0.8 cm2; SVI \< 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason) * I5. Heart team agrees on eligibility for TAVR * I6. Written informed consent * I7. Negative pregnancy test in women with childbearing potential Exclusion Criteria: * E1. Hemodynamic instability * E2. Cardiogenic shock * E3. Pre-existing mechanical or bio-prosthetic valve in any position * E4. Concomitant severe valvular heart disease * E5. Pre-existing or active endocarditis * E6. Need for heart surgery due to other conditions * E7. Aortic valve is congenital unicuspid or congenital bicuspid * E8. Hypertrophic cardiomyopathy with or without obstruction * E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation * E10. Acute myocardial infarction within 1 month before intended AS-treatment * E11. Renal replacement therapy * E12. Estimated life expectancy \< 24 months (730 days) due to carcinomas end stage liver disease or renal disease * E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. * E14. Patient refuses aortic valve repair