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MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting (NCT03024268)

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.
  • Device: Figulla Flex Occluder (Occlutech)
    Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Informed consent
    • Previous MitraClip implantation
    • Persistent relevant iASD 30 days after MitraClip intervention
    Exclusion Criteria:
    • Unsuccessful MitraClip implantation
    • No relevant iASD 30 days after MitraClip intervention
    • Unstable angina in the previous 4 weeks
    • Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy
    • Constrictive pericarditis / restrictive cardiomyopathies
    • Pericardial effusion planed for surgery or interventional therapy
    • Coagulation disorders
    • Malignant disease with a life expectance < 12 months
    • Pregnancy
    • Participation in another study
    • iASD diameter > 38 mm
    • Aortic minimum distance of the iASD < 5 mm
    • Thrombus in left atrial appendage
    • Venous access impossible with a 24 French catheter system
    • Presence of an inferior vena cava filter
    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).

    1 locations

    Germany (1)
    • Heart Center of the University Leipzig
      recruiting
      Leipzig, Germany, 04289
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 December, 2015
    Updated:
    18 January, 2017
    Participants:
    80
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