The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

Inclusion Criteria

• •Subject will be included if all of the following criteria are met:
• •* Patient with severe aortic stenosis defined by an aortic valve area (AVA) \< 1cm2 or AVA indexed to body surface area (BSA) of \< 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) \< 35ml/m2, as assessed by integration of echocardiographic and invasive measurements
• •* Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class \> I, angina or syncope)
• •* Patient is considered at high (STS-PROM (Society of Thoracic Surgeons-Predicted Risk of Mortality) score \>8) or intermediate (STS-PROM score \>4) risk by the Heart Team.
• •* The heart team agrees on eligibility of the patient for participation and that TAVR (Transcatheter aortic valve replacement) (TAVR) by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
• •* Aortic annulus dimensions suitable (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available
• •* Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography
• •* Written informed consent of the patient or her/his legal representative
• •* Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up