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

Mitral Valve Insufficiency Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03024268
Study type Interventional
Source Heart Center Leipzig - University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date January 2016
Completion date December 2021
View Details
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