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TAVR replacement of Stenotic Aortic Valve with ACURATE Neo2 Valve.

Trial ID:
IRB-19-7448
Paul S. Teirstein, M.D., FACC
The study will compare the safety and effectiveness of the investigational ACURATE Valve, compared to other commercially available TAVR devices (Control Valves).

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

Contact Info:

  • CRS Leadership
  • CRSLeadership@scrippshealth.org