TAVR replacement of Stenotic Aortic Valve with ACURATE Neo2 Valve.

Inclusion Criteria

• Have diagnosed severe symptomatic native aortic stenosis.
• Have NYHA Functional Class = II.
• Be capable and willing to return to the study hospital for all required scheduled follow up visits.
• Be able to take the protocol-required medications

Exclusion Criteria

• Have a unicuspid or bicuspid aortic valve, or a pre-existing prosthetic aortic or mitral valve.
• Have an acute myocardial infarction within 30 days prior to the index procedure.
• Have moderate or severe mitral stenosis.
• Have a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
• Have had a clinically significant bleeding requiring hospitalization or transfusion within the past 3 months
• Have known hypersensitivity to contrast agents
• Have hypertrophic cardiomyopathy.
• Be participating in another investigational drug or device study or intend to participate in another investigational device clinical trial within 12 months after index procedure.
• Have severe incapacitating dementia.

Additional Info

• All treatments and physician visits during this study will take place at Anderson Medical Pavilion.
• For more information, search for NCT03735667 at www.clinicaltrials.gov