REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

Inclusion Criteria

• Patient must be at least 70 years of age or older, and meets all of the criteria below.
• Patient has documented calcified native aortic valve stenosis, defined with an initial aortic valve area (AVA) of 40 mmHg or a jet velocity >4 m/s, as measured by echocardiography.
• The patient is considered at high risk for surgical aortic valve replacement with an STS (Society of Thoracic Surgeons) score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities.
• Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II.
• Patient has a documented aortic annulus size between 19 and 22 mm (able to accommodate the 23 mm Lotus™ Valve). Pre-procedure measurement by transthoracic echocardiography (TTE) is required. Other imaging modalities (e.g., transesophageal echocardiography (TEE), CT scan) can be used in an adjunctive manner.
• Patient (or legal representative) understands the trial requirements and the treatment procedures, and provides written informed consent.
• Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria

• Patient has a congenital unicuspid or bicuspid aortic valve.
• Patient with an acute myocardial infarction (MI) within 30 days of the index procedure (defined as Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation (WHO definition)).
• Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
• Patient is on dialysis or has serum creatinine level >3.0 mg/dL.
• Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
• Patient has >2+ mitral regurgitation or >2+ aortic regurgitation (ie., patient cannot have more than moderate mitral or aortic regurgitation).
• Moderate to severe pulmonary hypertension (PA systolic pressure >60 mm Hg) as assessed by transthoracic echocardiography.
• Patient has a need for emergency surgery for any reason.
• Patient has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
• Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
• Patient has Hgb 700, 000 cells/mm3, and white blood cell (WBC) count 5cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick (>5mm), protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
• Patient has a femoral artery lumen of <6.0 mm or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
• Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc).
• Patient is participating in another investigational drug or device study that has not reached its primary endpoint.
• Patient has preexisting untreated conduction system disorders: Type II second-degree atrioventricular (AV) block, bifascicular or trifascicular block.