REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Are you eligible to participate in this study?

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

  • Conditions:
    Severe Aortic Stenosis
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have documented severe aortic stenosis
    2. Subjects in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve
    3. Subjects with documented aortic annulus size of =20 mm and =27 mm based on the center’s assessment of pre-procedure diagnostic imaging
    4. Subjects with symptomatic aortic valve stenosis per IC1definition above with NYHA Functional Class = II.
    5. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality
    6. Heart team agrees that the subject is likely to benefit from valve replacement.
    7. Subjects have been informed of the study requirements and the treatment procedures, and provides written informed consent
    8. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
    9. Subjects are expected to be able to take the protocol-required adjunctive pharmacologic therapy

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

    1. Subjects with a unicuspid or bicuspid aortic valve
    2. Subjects had an acute myocardial infarction within 30 days prior
    3. Subjects had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior
    4. Subjects who are on renal replacement therapy or has or has GFR <20
    5. Subjects with pre-existing prosthetic aortic or mitral valve
    6. Subjects with severe (4+) aortic, tricuspid, or mitral regurgitation.
    7. Subjects who have moderate to severe mitral stenosis
    8. Subjects who needs for emergency surgery for any reason
    9. Subjects have history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis
    10. Subjects with chocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
    11. Subjects who have platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3
    12. Subjects who refuse transfusions or has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen
    13. Subjects with known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
    14. Subjects whose life expectancy of less than 24 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
    15. Subjects who have hypertrophic obstructive cardiomyopathy.
    16. Subjects has any therapeutic invasive cardiac or vascular procedure within 30 days prior
    17. Subjects with multivessel coronary artery disease with a Syntax score >22
    18. Subjects with severe left ventricular dysfunction with ejection fraction <20%
    19. Subjects who are in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
    20. Subjects who have arterial access that is not acceptable for the study device delivery system
    21. Subjects have severe vascular disease that would preclude safe access
    22. Subjects have current problems with substance abuse
    23. Subjects participating in another investigational drug or device study
    24. Subjects who have untreated conduction system disorder
    25. Subjects who have severe incapacitating dementia.

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