REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Exclusion Criteria

• •Subject has a congenital unicuspid or bicuspid aortic valve.
• •Subject with an acute myocardial infarction within 30 days of the index procedure
• •Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
• •Subject is on dialysis or has serum creatinine level \>3.0 mg/dL or 265 µmol/L.
• •Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
• •subject cannot have more than moderate mitral, aortic or tricuspid regurgitation
• •Subject has a need for emergency surgery for any reason.
• •Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
• •Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
• •Subject has low Hgb, platelet count or \>700,000 cells/mm3, or low white blood cell count.
• •Subject requires chronic anticoagulation therapy and cannot tolerate concomitant therapy with either aspirin or clopidogrel/ticlopidine
• •Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
• •Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, tantalum, titanium, or polyurethanes.
• •Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
• •Subject has hypertrophic obstructive cardiomyopathy.
• •Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
• •Subject has untreated coronary artery disease.
• •Subject has documented left ventricular ejection fraction \<30%.
• •Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
• •Subject has severe peripheral vascular disease or symptomatic carotid or vertebral disease.
• •Narrow Femoral artery lumen precludes the use of either Lotus device size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
• •Current problems with substance abuse (e.g., alcohol, etc.).
• •Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
• •Patient has preexisting untreated conduction system disorder that requires new pacemaker implantation.