PARTNER 3 Trial - Aortic Valve-in-Valve

Eligibility Criteria

• 1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
• 2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
• 3. NYHA Functional Class ≥ II.
• 4. Heart Team agrees the patient is low to intermediate risk.
• 5. Heart Team agrees valve implantation will likely benefit the patient.
• 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• 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