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

Not Applicable

• Conditions: Heart Septal Defects, Atrial; Mitral Valve Insufficiency
• Interventions: Device: Figulla Flex Occluder (Occlutech)

• Registration Number: NCT03024268
• Lead Sponsor: Heart Center Leipzig - University Hospital

Brief 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).

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Primary Completion: 2020-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: interventional closure of iASD	Figulla Flex Occluder (Occlutech)	Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)

Primary Outcome Measures

Name	Time	Method
Change in Exercise tolerance: 6 minute walking test	baseline, 3 and 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heart Center of the University Leipzig; 🇩🇪 Leipzig, Germany