NCT03453853

Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)

The Study for Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study): Multi-center, Open Label, Single Arm, Feasibility Test

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Tau-MEDICAL Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate second stage 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 and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.

Conditions

• Atrial Functional Mitral Regurgitation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Mitral Loop Cerclage Annuloplasty	Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-11-17
• Completion: 2021-04-03
• First posted: 2018-03-05
• Last updated: 2021-04-26

Locations

7 sites across 1 country: South Korea