Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

NCT Number	NCT02701283
Lead Sponsor	Medtronic Cardiovascular
Conditions	Aortic Valve Stenosis
Enrollment	2,223 participants
Start Date	2016-03
Primary Completion	2021-04 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-07