Testing Edwards SAPIEN 3/SAPIEN 3 Ultra THV for aortic stenosis

Exclusion

• −Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
• −Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more →)
• −Severe regurgitation (\> 3+) or stenosis of any other valve
• −Failing valve has moderate or severe paravalvular regurgitation
• −Failing valve is unstable, rocking, or not structurally intact
• −Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
• −Increased risk of embolization of THV
• −Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
• −Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
• −Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
• −Anatomical characteristics that would preclude safe access to the apex (Transapical)
• −Evidence of an acute myocardial infarction ≤ 30 days before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −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.
• −Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
• −Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• −Untreated clinically significant coronary artery disease requiring revascularization
• −Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
• −Emergency interventionalInterventional studyA study where participants are given something to see what happens.Read more →/surgical procedures within 30 days prior to the procedure
• −Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → from the procedure
• −Hypertrophic cardiomyopathy with obstruction
• −LVEF \< 30%
• −Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• −Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
• −Stroke or transient ischemic attack within 90 days of enrollment
• −Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
• −Renal insufficiency and/or renal replacement therapy at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Active bacterial endocarditis within 180 days of the procedure
• −Patient refuses blood products
• −Estimated life expectancy \< 24 months
• −Currently participating in an investigational drug or another device study
• −Positive urine or serum pregnancy test in female subjects of childbearing potential