TAVR replacement of Stenotic Aortic Valve with ACURATE Neo2 Valve.

Trial ID:
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

Patients must:
  • 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

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.

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