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

Eligibility Criteria

• 1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• 2. Bioprosthetic valve size suitable for SAPIEN X4 THV
• 3. NYHA functional class ≥ II
• 4. Heart Team agrees the subject is at high or greater surgical risk
• 5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• 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