Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Conditions studied

Aortic Valve Stenosis

What is being tested

• DEVICE: Medtronic Transcatheter Aortic Valve Replacement Systems
• DEVICE: Surgical Aortic Valve Replacement (SAVR)

What it measures

• Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study, Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke)., Randomized Controlled Trial - 24 months Continued Access Study - 12 months