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AVJ-514 Japan Trial

NCT02520310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-11

Study results available
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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

Interventions

DEVICE

AVJ-514

Patients receiving AVJ-514 device

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ryohei Yozu, MD, PhD · Keio University

  • Morimasa Takayama, MD, PhD · Sakakibara Heart Institute

  • Peter Staehr, MD · Abbott Vascular, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-07
Primary Completion
2016-07-31
Completion
2021-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520310 on ClinicalTrials.gov