Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
研究概览
简要总结
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.
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
盲法说明
Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
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
- •Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
- •Signs and symptoms of left-sided heart failure.
- •Left-ventricular ejection fraction ≥50%
- •Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg)
排除标准
- •Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
- •Moderate aortic stenosis.
- •Pregnancy
- •Contraindication to perform cardiac magnetic resonance imaging.
- •Conditions rendering patient unable to give informed consent to the study protocol.
结局指标
主要结局
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
时间窗: Periprocedural.
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
次要结局
- Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.(Periprocedural.)
- Change in dPdtmin(Periprocedural.)
- Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)(Periprocedural.)
- Change in the early diastolic filling pattern as assessed by MRI.(Baseline and 1-month follow-up following TTVR.)
研究者
Philipp Lurz
Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital