CoreValve® System Australia/New Zealand Clinical Study

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Inclusion criteria

• Documented severe aortic valve stenosis
• Access vessel diameter >6 mm as defined pre procedure via angiographic measure
• Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
• Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
• Native aortic valve disease, defined as valve stenosis with an aortic valve area<1cm2 (<0.6cm2 /m2) as defined pre procedure by echocardiographic measure

AND (Assessment of Surgical Risk)

Age ≥ 80 years

AND/OR

Surgical risk calculated with logistic EuroSCORE ≥ 20%,

AND/OR

Age ≥ 65 years with one or two (but not more than 2) of the following criteria:

• Cirrhosis of the liver (Child class A or B)
• Pulmonary insufficiency : VMS < 1 liter
• Previous cardiac surgery (CABG, valvular surgery)
• Porcelain aorta
• Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement
• Recurrent pulmonary embolus
• Right ventricular insufficiency
• Thoracic burning sequelae contraindicating open chest surgery
• History of mediastinum radiotherapy
• Severe connective tissue disease resulting in a contraindication to surgery
• Cachexia (clinical impression)
• Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion criteria

• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
• Any sepsis, including active endocarditis.
• Recent myocardial infarction (<30 days)
• Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
• Uncontrolled atrial fibrillation
• Mitral or tricuspid valvular insufficiency (> grade II)
• Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
• Evolutive or recent CVA (cerebrovascular accident), (<3 months)
• Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
• Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
• Abdominal or thoracic aortic aneurysm
• Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
• Evolutive disease with life expectancy less than one year
• Creatinine clearance < 20 ml/min
• Active gastritis or known peptic ulcer disease
• Pregnancy