NCT02746809

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

Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (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 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.

Detailed 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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	CoreValve Evolut 34R TAVR system	The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut 34R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS)

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2021-12-15
• First posted: 2016-04-21
• Last updated: 2023-05-03
• Results posted: 2017-12-29

Locations

10 sites across 1 country: United States