AVJ-514 Japan Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02520310
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	September 7, 2015
Completion date	May 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06465745` - AltaValve Pivotal Trial	N/A
Completed	`NCT02355418` - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Recruiting	`NCT04577248` - The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Recruiting	`NCT03242642` - Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.	N/A
Recruiting	`NCT02961647` - Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI)	N/A
Active, not recruiting	`NCT02302872` - Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation	N/A
Completed	`NCT01777815` - Safety and Performance Study of the NeoChord Device	N/A
Withdrawn	`NCT00428103` - Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy	N/A
Completed	`NCT04351984` - Transcatheter Mitral Valvuloplasty Pilot Study
Withdrawn	`NCT02722551` - CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study	Phase 1/Phase 2
Active, not recruiting	`NCT02321514` - Expanded Clinical Study of the Tendyne Mitral Valve System	N/A
Recruiting	`NCT02245763` - STS/ACC TVT Registry Mitral Module
Active, not recruiting	`NCT01740583` - Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation	N/A
Completed	`NCT00800046` - A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study	N/A
Completed	`NCT00415701` - Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery	Phase 4
Recruiting	`NCT03908983` - OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation	N/A
Active, not recruiting	`NCT04818502` - Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Terminated	`NCT03285724` - Safety and Performance Study of the Harpoon Mitral Valve Repair System	N/A
Recruiting	`NCT04195984` - Mi-thos® Transcatheter Mitral Valve Replacement Study	N/A
Active, not recruiting	`NCT04281940` - Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)	N/A