NCT02207569

Medtronic CoreValve Evolut R U.S. Clinical Study

Medtronic CoreValve Evolut R United States IDE Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	CoreValve Evolut R TAVR system

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• Completion: 2020-10-28
• First posted: 2014-08-04
• Last updated: 2022-11-02
• Results posted: 2017-12-12

Locations

23 sites across 1 country: United States