NCT02607527

Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Detailed description

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery. This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015. Subjects will undergo transcatheter implantation of the Millipede IRIS implant.

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Mitral Valve IRIS Ring	Transcatheter implantation of the IRIS

Timeline

• Start date: 2017-05-08
• Primary completion: 2019-01-17
• Completion: 2019-12-19
• First posted: 2015-11-18
• Last updated: 2024-10-24

Locations

2 sites across 2 countries: Brazil, Paraguay

Regulatory

• FDA-regulated device study