NCT02718001

Edwards EVOQUE Eos MISCEND Study

Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

Detailed description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.

Conditions

• Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Type	Name	Description
DEVICE	Edwards EVOQUE Eos Mitral Valve Replacement System	Replacement of the mitral valve through a transcatheter approach

Timeline

• Start date: 2015-02-06
• Primary completion: 2028-04-30
• Completion: 2033-04-30
• First posted: 2016-03-24
• Last updated: 2026-04-13

Locations

19 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study