Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)

Status Completed

Clinical Trial Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.

Clinical Trial Description

This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT02746809
Study type	Interventional
Source	Medtronic Cardiovascular
Contact
Status	Completed
Phase	N/A
Start date	June 2016
Completion date	December 15, 2021

View Details

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