Clinical Trial: AVJ-514 Japan Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Abbott Vascular

Current Primary Outcome:

  • Primary safety composite as measured by freedom from Major Adverse Events (MAE) [ Time Frame: 30 days ]
    MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary efficacy as measured by Acute Procedure Success (APS) [ Time Frame: At discharge or at 30 days ]
    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 (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable). Patients who die or who undergo mitral valve surgery before discharge are an APS failure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All-cause mortality [ Time Frame: 12 months ]
  • All-cause mortality [ Time Frame: 24 months ]
  • All-cause mortality [ Time Frame: 3 years ]
  • All-cause mortality [ Time Frame: 4 years ]
  • All-cause mortality [ Time Frame: 5 years ]
  • Freedom from the components of the primary safety composite of MAE [ Time Frame: 12 months ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Freedom from the components of the primary safety composite of MAE [ Time Frame: 24 months ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Freedom from the components of the primary safety composite of MAE [ Time Frame: 3 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Freedom from the components of the primary safety composite of MAE [ Time Frame: 4 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Freedom from the components of the primary safety composite of MAE [ Time Frame: 5 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary safety composite as measured by freedom from MAE [ Time Frame: 12 months ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary safety composite as measured by freedom from MAE [ Time Frame: 24 months ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary safety composite as measured by freedom from MAE [ Time Frame: 3 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary safety composite as measured by freedom from MAE [ Time Frame: 4 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • Primary safety composite as measured by freedom from MAE [ Time Frame: 5 years ]
    MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
  • New York Heart Association (NHYA) Functional Class [ Time Frame: At baseline ]
    Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
  • NHYA Functional Class [ Time Frame: 30 days ]
    Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac d

    Original Secondary Outcome: Same as current

    Information By: Abbott Vascular

    Dates:
    Date Received: July 17, 2015
    Date Started: August 2015
    Date Completion: April 2021
    Last Updated: October 20, 2016
    Last Verified: October 2016