Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
研究概览
简要总结
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.
排除标准
- •Patient with Incompatibility with magnetic resonance imaging or echocardiography
- •Another valve disorder that requires treatment
- •Severe precapillary pulmonary hypertension
- •Unstable angina or percutaneous coronary intervention within the last 30 days
- •Previous pacemaker/defibrillator implantation with intracardiac leads
- •Patients with cardiac cachexia or a life expectancy less then 12 months
- •Allergies to the material used.
结局指标
主要结局
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
时间窗: 3 Month
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
时间窗: 3 Month
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
时间窗: 3 Month
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
时间窗: 3 month
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
时间窗: 3 Month
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
时间窗: 3 Month
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
时间窗: 3 Month
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
次要结局
- rehospitalization rate(3 month)
- Exercise Testing with 6 min walking test(3 month)
- Stroke(3 month)
- Death due to cardiovascular complication(3 month)
- Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity(3 month)
研究者
Muhammed Gerçek
Principal Investigator
Heart and Diabetes Center North-Rhine Westfalia