ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Exclusion Criteria

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