ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

Exclusion Criteria

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