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The study will compare the safety and effectiveness of the investigational ACURATE Valve, compared to other commercially available TAVR devices (Control Valves).
- Trial ID:
- Paul S. Teirstein, M.D., FACC
- 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
Patients must not:
- 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.
- 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