Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA

Inclusion criteria

• 70 years of age or older
• Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
• Symptomatology due to aortic stenosis resulting in one of the following:

• NYHA Functional Classification of II or greater
• Presence of angina
• Presence of syncope
• Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
• STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
• Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion criteria

• Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
• Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm)
• Patients with low flow/low gradient aortic stenosis
• Patients with significant annular calcification (e.g. Agatston score > 4000)
• Pre-existing prosthetic heart valve in any position, or prosthetic ring
• Severe aortic, mitral or tricuspid valve regurgitation
• Moderate to severe mitral stenosis
• Myocardial infarction within the past 30 days*
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• LVEF < 30%
• Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
• Hemodynamic instability requiring inotropic drug therapy within the past 14 days
• Untreated clinically significant coronary artery disease requiring revascularization
• Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
• Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
• Patient ineligible for or refuses blood transfusions
• Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
• Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
• Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 month, or treatment of carotid stenosis within past two months*
• Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
• Active infection requiring ongoing treatment
• Need for emergent surgery or intervention other than the investigational procedure
• Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure except for PCI which is within 7 days of the index procedure*
• Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
• Life expectancy < 1 year due to non-cardiac co-morbid conditions
• Currently participating in any investigational drug or device studies that may confound the results of this study
• History of any cognitive or mental health status that would interfere with study participation * At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility.