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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Mitral Valve Insufficiency, Heart Septal Defects, Atrial

Intervention / Treatment
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* Device: Figulla Flex Occluder (Occlutech)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: interventional closure of iASD<br>Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech) | Device: Figulla Flex Occluder (Occlutech)<br>* Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)<br>|
| No Intervention: B: no intervention<br>Best medical supportive care (n=40) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise tolerance: 6 minute walking test |  | baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in New York Heart Association Functional Classification assessment | Changes in New York Heart Association Functional Classification | baseline, 3 and 6 months | 
| Changes in Echocardiography: bi ventricular function (2D and 3D) |  | baseline, 3 and 6 months | 
| Changes in Echocardiography: assessment of left atrium (2D and 3D) |  | baseline, 3 and 6 months | 
| Changes in Echocardiography: assessment of heart valves |  | baseline, 3 and 6 months | 
| Changes in Echocardiography: strain using speckle tracking |  | baseline, 3 and 6 months | 
| Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D) |  | baseline, 3 and 6 months | 
| Heart insufficiency bio markers |  | baseline and 6 months | 
| Changes in Cardiac MRI: bi ventricular function |  | baseline and 6 months | 
| Changes in Cardiac MRI: left ventricular longitudinal strain |  | baseline and 6 months | 
| Changes in Cardiac MRI: left ventricular circumferential strain |  | baseline and 6 months | 
| Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta |  | baseline and 6 months | 
| Evaluation of hospitalisation rate | Telephone | baseline, 3, 6 and 12 months | 
| Evaluation of mortality | Telephone | baseline, 3, 6 and 12 months | 
| Combined endpoint (hospitalisation and mortality) | Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity. | baseline, 3, 6 and 12 months | 
| Changes in quality of life in Minnesota Living with Heart Failure questionnaire |  | baseline and 6 months | 
| Changes in quality of life in Short Form - 36 questionnaire |  | baseline and 6 months |