Clinical Research Studies

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 21 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  High Risk Cohort

  1. Subjects must have co-morbidities such that the surgeon and cardiologist Co-Investigators concur that the predicted risk of operative mortality is =15% or a minimum STS score of 8%.
  2. Subjects must be at least 21 years old
  3. Subjects have senile degenerative aortic valve stenosis with echocardiographically derived criteria as per protocol
  4. Subjects have symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV
  5. Subjects has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
  6. Subjects agree to return for all required post-procedure follow-up visits.
  7. Subjects have aortic annulus that measured 19-27mm diameter (by CT conducted within 12 months prior)
  8. Extreme Risk Cohort: Subjects must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and after formal consultations conclude that the irreversible morbidity exceeds the probability of meaningful improvement

  
  

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

• High and Extreme Risk Cohort:

  1. Subjects with evidence of an acute myocardial infarction
  2. Subjects with aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified as verified by echocardiography
  3. Subjects with mixed aortic valve disease
  4. Subjects with any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure
  5. Subjects with pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC)
  6. Subjects with blood dyscrasias
  7. Subjects who have history of bleeding diathesis or coagulopathy
  8. Subjects with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  9. Subjects who have untreated clinically significant coronary artery disease requiring revascularization
  10. Subjects with hemodynamic instability requiring inotropic support or mechanical heart assistance
  11. Subjects who need for emergency surgery for any reason
  12. Subjects who have hypertrophic cardiomyopathy with or without obstruction (HOCM)
  13. Subjects with severe ventricular dysfunction with LVEF <20% as measured by resting echocardiogram.
  14. Subjects who had echocardiographic evidence of intracardiac mass, thrombus or vegetation
  15. Subjects with active peptic ulcer or upper GI bleeding within 3 months prior to index procedure
  16. Subjects have known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated
  17. Subjects had a recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  18. Subjects with renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis
  19. Subjects who have a life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions
  20. Subjects with significant aortic disease
  21. Subjects who have native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging
  22. Subjects with aortic root angulation > 70° (applicable for transfemoral patients only)
  23. Subjects who are currently participating in an investigational drug or device study
  24. Subjects who have active bacterial endocarditis within 6 months prior to the index procedure
  25. Subjects with bulky calcified aortic valve leaflets in close proximity to coronary ostia
  26. Subjects with non-calcified aortic annulus
  27. Subjects with iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath such as severe obstructive calcification, or severe tortuosity (applicable for transfemoral patients only)