SMART

Conditions studied

Aortic Valve Replacement, Aortic Valve Stenosis, Symptomatic Aortic Stenosis

What is being tested

• DEVICE: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
• DEVICE: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems

What it measures

• Bioprosthetic Valve Dysfunction (BVD), Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)), 12 months
• Mortality, Disabling Stroke or Heart Failure Rehospitalization, Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization., 12 months