Clinical Trial: A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A RandomizEd Study of tHe MitrACliP DEvice in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

Brief Summary: To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.

Detailed Summary: The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.
Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Current Primary Outcome: cardiovascular (CV) death [ Time Frame: 24 months ]

Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mitral Regurgitation (MR) severity reduction [ Time Frame: at 12 and 24 months ]
    Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months;
  • Change in 6 Minute Walk Test (6MWT) [ Time Frame: at 6, 12 and 24 months ]
    Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline;
  • CV hospitalizations and CV death [ Time Frame: 24 months ]
    Rate of recurrent CV hospitalizations and CV death
  • Quality of Life (QoL) overall score [ Time Frame: 12 months ]
    Change in Quality of Life (QoL) overall score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline
  • New York Heart Association (NYHA) Functional Class [ Time Frame: at 6, 12 and 24 months ]
    Change in New York Heart Association (NYHA) Functional Class over baseline and proportions of patients in NYHA Functional Class I/II at 6, 12 and 24 months
  • Patient-reported Global Assessment (PGA) [ Time Frame: at 6, 12 and 24 months ]
    Change in Patient-reported Global Assessment (PGA) of well-being at 6, 12 and 24 months


Original Secondary Outcome: Same as current

Information By: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Dates:
Date Received: May 12, 2015
Date Started: March 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016