NCT02520310

AVJ-514 Japan Trial

A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.

Detailed description

This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team. Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.

Conditions

• Mitral Stenosis With Insufficiency
• Functional Mitral Regurgitation
• Mitral Insufficiency
• Mitral Valve Incompetence
• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	AVJ-514	Patients receiving AVJ-514 device

Timeline

• Start date: 2015-09-07
• Primary completion: 2016-07-01
• Completion: 2021-05-31
• First posted: 2015-08-11
• Last updated: 2021-06-11
• Results posted: 2019-09-19

Locations

6 sites across 1 country: Japan