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

Heart Center Leipzig - University Hospital

Status: Unknown

Conditions: Mitral Valve Insufficiency; Heart Septal Defects, Atrial

Treatments: Device: Figulla Flex Occluder (Occlutech)

Study type: Interventional

Funder types: Other

Identifiers

NCT03024268

MITHRAS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

A: interventional closure of iASD

Experimental group

Description:

Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)

Treatment:

Device: Figulla Flex Occluder (Occlutech)

B: no intervention

No Intervention group

Description:

Best medical supportive care (n=40)