Medtronic CoreValve Evolut R U.S. Clinical Study

Status Completed

Clinical Trial Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis 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 a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 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. The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02207569
Study type	Interventional
Source	Medtronic Cardiovascular
Contact
Status	Completed
Phase	N/A
Start date	August 2014
Completion date	October 28, 2020

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