ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System

The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.

The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.

The secondary objective is to evaluate adverse events and study device performance.

Inclusion criteria

• Patient 75 years of age and older
• Severe aortic stenosis defined as:

• Mean aortic gradient > 40 mmHg or
• Peak jet velocity > 4.0 m/s or
• Aortic valve area of < 1.0 cm2
• High risk candidate for conventional AVR defined as:

• Logistic EuroSCORE 1 ≥ 20% or
• STS Score ≥ 8% or
• Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis
• NYHA Functional Class > II
• Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
• Patient willing to participate in the study and provides signed informed consent

Exclusion criteria

• Congenital aortic stenosis or unicuspid or bicuspid aortic valve
• Non-stenotic Aortic Insufficiency
• Severe eccentricity of calcification
• Severe mitral regurgitation (>2+)
• Presence of mitral bioprosthesis
• Presence of previously implanted aortic bioprosthesis
• Presence of prosthetic ring
• Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
• Thoracic (TAA) or abdominal (AAA) aortic aneurysm
• Presence of endovascular stent graft for treatment of TAA or AAA
• Trans-oesophageal echocardiogram (TEE) is contraindicated
• Evidence of intra-cardiac mass, thrombus or vegetation
• Severe ventricular dysfunction with ejection fraction < 20%
• Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
• Acute Myocardial Infarction within 1 month prior to implant procedure
• Previous TIA or stroke within 3 months prior to implant procedure
• Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
• Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
• Severe coagulation conditions
• Refusal of blood transfusions
• Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
• Hypertrophic cardiomyopathy with or without obstruction
• Active bacterial endocarditis or other active infections
• Hepatic failure (> Child B)
• Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
• Refusal of surgery
• Severe COPD requiring home oxygen
• Neurological disease severely affecting ambulation or daily functioning, or dementia
• Life expectancy < 12 months due to non-cardiac co-morbid conditions
• Inability to tolerate anticoagulation therapy
• Contraindication to contrast media or allergy to nickel
• Currently participating in an investigational drug or another device study
• Non-valvular aortic stenosis
• Non-calcific acquired aortic stenosis