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AVJ-514 Japan Trial | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT02520310•Abbott Medical Devices

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 20 years or older.
•2. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
•3. Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
•4. New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
•5. Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:
•* Porcelain aorta or mobile ascending aortic atheroma
•* Post-radiation mediastinum
•* Previous mediastinitis
•* Functional MR with LVEF \< 40%
•* Over 75 years old with LVEF \< 40%
+9 more criteria

Exclusion Criteria

•1. LVEF is \< 30%
•2. Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes:
•* Insufficient mobile leaflet available for grasping with the AVJ-514 device
•* Lack of both primary and secondary chordal support in the grasping area
•* Evidence of significant calcification in the grasping area
•* Presence of a significant cleft in the grasping area
•3. Life expectancy \< 1 year due to associated non-cardiac co-morbid conditions
•4. Need for emergent or urgent surgery for any reason
•5. Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
•6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
+22 more criteria

Locations (6)

Shonan Kamakura General Hospital

Kanagawa, Japan

Sendai Kosei Hospital

Miyagi, Japan

National Cerebral and Cardiovascular Center

Osaka, Japan

Keio University Hospital

Tokyo, Japan

Sakakibara Heart Institute

Tokyo, Japan

Tokyo Women's Medical University Hospital

Tokyo, Japan

Key Dates

Start Date

September 7, 2015

Primary Completion Date

July 1, 2016

Completion Date

May 31, 2021

Last Updated

June 11, 2021

Enrollment

ACTUAL participants

Conditions

Mitral Stenosis With InsufficiencyFunctional Mitral RegurgitationMitral InsufficiencyMitral Valve IncompetenceMitral Valve Regurgitation

Interventions

AVJ-514

DEVICE

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

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RECRUITINGNA

AltaValve Pivotal Trial

NCT06465745

Mitral RegurgitationMitral Insufficiency+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AVJ-514 Japan Trial

Inclusion Criteria

Exclusion Criteria

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

AltaValve Pivotal Trial

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM)