NCT03024268

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Mitral Valve Insufficiency
• Heart Septal Defects, Atrial

Interventions

Type	Name	Description
DEVICE	Figulla Flex Occluder (Occlutech)	Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-09-01
• Completion: 2021-12-01
• First posted: 2017-01-18
• Last updated: 2021-05-10

Locations

1 site across 1 country: Germany