Summary

Transcatheter aortic valve replacement (TAVR) is less invasive than surgical aortic valve replacement for patients with degenerative aortic stenosis who have a high risk of surgical complications. The purpose of the Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [CoreValve Extreme Risk; NCT01240902] was to evaluate the safety and efficacy of the CoreValve transcatheter heart valve for the treatment of symptomatic severe aortic stenosis in patients with a =50% risk of operative mortality or serious, irreversible morbidity at 30 days.