MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
- Conditions
- Heart Septal Defects, AtrialMitral Valve Insufficiency
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Informed consent
- Previous MitraClip implantation
- Persistent relevant iASD 30 days after MitraClip intervention
- 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
- 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 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.
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 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
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 Heart insufficiency bio markers baseline and 6 months
Trial Locations
- Locations (1)
Heart Center of the University Leipzig
🇩🇪Leipzig, Germany
Heart Center of the University Leipzig🇩🇪Leipzig, Germany