ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)

ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.

A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.

Inclusion Criteria:

1. Patients at least 75 years of age
2. Additive EuroSCORE > 9
3. Severe AS assessed by echocardiography and documented by a mean gradient > 40mmHg and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²
4. NYHA Functional Class > II
5. Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
6. Patient understands the implications of participating in the study and provides signed informed consent

Exclusion Criteria:

1. Congenital unicuspid or bicuspid aortic valve
2. Severe eccentricity of calcification
3. Severe mitral regurgitation (> 2°)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. Severe transapical access problem, non-reachable LV apex
6. Previous surgery of the LV using a patch, such as the Dor procedure
7. Presence of apical LV thrombus
8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
9. Acute myocardial infarction (AMI) within 1 month prior to the procedure
10. PCI within 1 month prior to the procedure
11. Previous transient ischemic attack (TIA) or stroke in the last 3 months
12. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
13. Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
14. Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
15. Calcified pericardium
16. Septal hypertrophy unacceptable for transapical procedure
17. Primary hypertrophic obstructive cardiomyopathy (HOCM)
18. Active infection, endocarditis or pyrexia
19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
20. Significant hepatic involvement (Child > B)
21. Severe COPD requiring home oxygen
22. History of bleeding diathesis or coagulopathy
23. Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
24. Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
25. Neurological disease severely affecting ambulation or daily functioning, including dementia
26. Another surgical or percutaneous procedure scheduled at the same time
27. Emergency procedure
28. Life expectancy < 12 months due to non-cardiac co-morbid conditions
29. Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
30. Currently participating in an investigational drug or another device study