AVJ-514 Japan Trial

NCT02520310 | Completed Results DMC

• 1 other identifier: AVJ-514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

Mitral Regurgitation; mitral valve surgery; AVJ-514 Delivery System; Symptomatic Heart Failure; Heart Valve Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Procedure Success (APS)

  APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

  On day 0 (the day of procedure)

Secondary Outcomes (225)

• Percentage of Participants With Major Adverse Events (MAE) at 30 Days

  30 days

• Percentage of Participants With MAE at 1 Year

  1 year

• Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access

  30 days

• Number of Participants With Mitral Valve Stenosis Requiring Surgery

  1 year

• Number of Participants With Mitral Valve Stenosis Not Requiring Surgery

  1 year

Study Arms (1)

AVJ-514

EXPERIMENTAL

The AVJ-514 system

Device: AVJ-514

Interventions

AVJ-514 DEVICE

Patients receiving AVJ-514 device

AVJ-514

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or older.
• 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.
• 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).
• New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
• 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%
• Re-operation with patent grafts
• Two or more prior cardiothoracic surgeries
• Hepatic cirrhosis
• Other surgical risk factor(s)
• Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE.

You may not qualify if:

• LVEF is \< 30%
• 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
• Life expectancy \< 1 year due to associated non-cardiac co-morbid conditions
• Need for emergent or urgent surgery for any reason
• Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
• Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration.
• Cerebrovascular accident within 180 days prior to registration
• Severe symptomatic carotid stenosis (\> 70% by ultrasound)
• Any cardiac surgery within 180 days prior to registration

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Shonan Kamakura General Hospital

Kanagawa, Japan

Location

Sendai Kosei Hospital

Miyagi, Japan

Location

National Cerebral and Cardiovascular Center

Osaka, Japan

Location

Keio University Hospital

Tokyo, Japan

Location

Sakakibara Heart Institute

Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, Japan

Location

Related Publications (1)

• Hayashida K, Yasuda S, Matsumoto T, Amaki M, Mizuno S, Tobaru T, Jujo K, Ootomo T, Yamaguchi J, Fukuda K, Saito S, Foster E, Qasim A, Kitakaze M, Yozu R, Takayama M. AVJ-514 Trial - Baseline Characteristics and 30-Day Outcomes Following MitraClip(R) Treatment in a Japanese Cohort. Circ J. 2017 Jul 25;81(8):1116-1122. doi: 10.1253/circj.CJ-17-0115. Epub 2017 Mar 17.

  PMID: 28321004 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sripad Bellary
• Organization: Abbott Structural Heart

sripad.bellary@abbott.com

650-353-1726

Study Officials

• Ryohei Yozu, MD, PhD

  Keio University

  PRINCIPAL INVESTIGATOR

• Morimasa Takayama, MD, PhD

  Sakakibara Heart Institute

  PRINCIPAL INVESTIGATOR

• Peter Staehr, MD

  Abbott Vascular, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: August 11, 2015
• Study Start: September 7, 2015
• Primary Completion: July 1, 2016
• Study Completion: May 31, 2021
• Last Updated: June 11, 2021
• Results First Posted: September 19, 2019

Record last verified: 2021-06

Locations

JP (6)