REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

• Primary Device Performance Endpoint: Mean aortic valve pressure gradient at 30 days post implant procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
• Primary Safety Endpoint: All-cause mortality at 30 days post implant procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  All-cause mortality at 30 days post implant procedure

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Inclusion Criteria:

• Subject is ≥70 years of age
• Subject has documented calcific native aortic valve stenosis
• Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
• Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
• Subject is considered high risk for surgical valve replacement
• Heart team assessment that the subject is likely to benefit from valve replacement.
• Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
• Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

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.