MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure (NCT03024268) | Clinical Trial Compass
UnknownNot Applicable
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
Germany80 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Exercise tolerance: 6 minute walking test