NCT02722551

CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

Detailed description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve	Replacement of the mitral valve through a transcatheter approach

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-10-01
• Completion: 2024-10-01
• First posted: 2016-03-30
• Last updated: 2018-01-09

Locations

15 sites across 7 countries: Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland