MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Exercise tolerance: 6 minute walking test
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Previous MitraClip implantation
- •Persistent relevant iASD 30 days after MitraClip intervention
排除标准
- •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
结局指标
主要结局
Change in Exercise tolerance: 6 minute walking test
时间窗: baseline, 3 and 6 months
次要结局
- 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)
- 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)
- Change in New York Heart Association Functional Classification assessment(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: evaluation of iatrogenic ASD (2D and 3D)(baseline, 3 and 6 months)
- Heart insufficiency bio markers(baseline and 6 months)
- Evaluation of mortality(baseline, 3, 6 and 12 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)
研究者
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital