Clinical Trial: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure

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

Official Title: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting

Brief Summary: Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.

Detailed Summary:

Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.

The purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).


Sponsor: University of Leipzig

Current Primary Outcome: Change in Exercise tolerance: 6 minute walking test [ Time Frame: baseline, 3 and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in New York Heart Association Functional Classification assessment [ Time Frame: baseline, 3 and 6 months ]
    Changes in New York Heart Association Functional Classification
  • Changes in Echocardiography: bi ventricular function (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  • Changes in Echocardiography: assessment of left atrium (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  • Changes in Echocardiography: assessment of heart valves [ Time Frame: baseline, 3 and 6 months ]
  • Changes in Echocardiography: strain using speckle tracking [ Time Frame: baseline, 3 and 6 months ]
  • Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  • Heart insufficiency bio markers [ Time Frame: baseline and 6 months ]
  • Changes in Cardiac MRI: bi ventricular function [ Time Frame: baseline and 6 months ]
  • Changes in Cardiac MRI: left ventricular longitudinal strain [ Time Frame: baseline and 6 months ]
  • Changes in Cardiac MRI: left ventricular circumferential strain [ Time Frame: baseline and 6 months ]
  • Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta [ Time Frame: baseline and 6 months ]
  • Evaluation of hospitalisation rate [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone
  • Evaluation of mortality [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone
  • Combined endpoint (hospitalisation and mortality) [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.
  • Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire [ Time Frame: baseline and 6 months ]
  • Changes in quality of life in "Short Form - 36" questionnaire [ Time Frame: baseline and 6 months ]


Original Secondary Outcome: Same as current

Information By: University of Leipzig

Dates:
Date Received: December 29, 2016
Date Started: January 2016
Date Completion: July 2019
Last Updated: January 19, 2017
Last Verified: January 2017