PARTNER 3 Trial - Aortic Valve-in-Valve

Exclusion Criteria

• •1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
• •2. Severe regurgitation (\> 3+) or stenosis of any other valve
• •3. Failing valve has moderate or severe paravalvular regurgitation
• •4. Failing valve is unstable, rocking, or not structurally intact
• •5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
• •6. Increased risk of embolization of THV
• •7. Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
• •8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
• •9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
• •10. Anatomical characteristics that would preclude safe access to the apex (Transapical)
• •11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment
• •12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
• •13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
• •14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• •15. Untreated clinically significant coronary artery disease requiring revascularization
• •16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
• •17. Emergency interventional/surgical procedures within 30 days prior to the procedure
• •18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
• •19. Hypertrophic cardiomyopathy with obstruction
• •20. LVEF \< 30%
• •21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• •22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
• •23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
• •24. Stroke or transient ischemic attack within 90 days of enrollment
• •25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
• •26. Renal insufficiency and/or renal replacement therapy at the time of screening
• •27. Active bacterial endocarditis within 180 days of the procedure
• •28. Patient refuses blood products
• •29. Estimated life expectancy \< 24 months
• •30. Positive urine or serum pregnancy test in female subjects of childbearing potential
• •31. Currently participating in an investigational drug or another device study