NCT02471664

Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Tau-MEDICAL Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

Detailed description

The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.

Conditions

• Functional Mitral Regurgitation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Mitral Loop Cerclage Annuloplasty

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2016-07-01
• First posted: 2015-06-15
• Last updated: 2017-10-13

Locations

2 sites across 2 countries: United States, South Korea