Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Surgical Risk Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Aortic Stenosis
  • Age: Between 18 Year(s) - 120 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. You have been diagnosed with severe, symptomatic aortic stenosis.
    2. It has been determined by your physician that you are low or intermediate surgical risk and a transcatheter valve is appropriate for you.

You may not be eligible for this study if the following are true:

    1. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for women of childbearing potential.
    2. Need for emergency surgery for any reason.
    3. Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial.



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