- 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
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2. Failing valve has moderate or severe paravalvular regurgitation
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3. Failing valve is unstable, rocking, or not structurally intact
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4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
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5. Increased risk of THV embolization
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6. Surgical or transcatheter valve in the mitral position
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7. Severe mitral regurgitation (\> 3+) or = moderate mitral stenosis
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8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
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9. Left ventricular ejection fraction \< 20%
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10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
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11. Increased risk of coronary artery obstruction after THV implantation
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12. Myocardial infarction within 30 days prior to the study procedure
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13. Hypertrophic cardiomyopathy with subvalvular obstruction
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14. Subjects with planned concomitant ablation for atrial fibrillation
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15. Clinically significant coronary artery disease requiring revascularization
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16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
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17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
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18. Endocarditis within 180 days prior to the study procedure
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19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
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20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
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21. Renal insufficiency and/or renal replacement therapy
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22. Leukopenia, anemia, thrombocytopenia
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23. Inability to tolerate or condition precluding treatment with antithrombotic therapy
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24. Hypercoagulable state or other condition that increases risk of thrombosis
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25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
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26. Subject refuses blood products
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27. Body mass index \> 50 kg/m2
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28. Estimated life expectancy \< 24 months
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29. Female who is pregnant or lactating
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30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
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31. Participating in another investigational drug or device study that has not reached its primary endpoint
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32. Subject considered to be part of a vulnerable population
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