MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Informed consent
• Previous MitraClip implantation
• Persistent relevant iASD 30 days after MitraClip intervention
Locations
Other Locations
Germany
Heart Center of the University Leipzig
Leipzig
Time Frame
Start Date: 2016-01
Completion Date: 2021-12
Participants
Target number of participants: 80
Treatments
Experimental: A: interventional closure of iASD
Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)
No_intervention: B: no intervention
Best medical supportive care (n=40)
Authors
Related Therapeutic Areas
Sponsors
Leads: Heart Center Leipzig - University Hospital