Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 44
- 主要终点
- Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
研究概览
简要总结
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters, physical capacity and quality of life. A continuous measurement of the left-ventricular volume would provide information about heart performance and could be used for both heart failure monitoring and optimization of CRT-therapy.
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
- •De novo CRT-patients
- •Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true bipolar RV-lead
- •NYHA class II or III
- •QRS ≥ 150 ms
- •LVEF between 15% and 35%
- •LVEDD ≥ 55 mm
- •Evaluable echo measurements
排除标准
- •Persistent or permanent atrial fibrillation
- •Heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
- •Non-ambulatory patients
- •Chronic renal dialysis
- •Life expectancy less than 1 year due to a non-cardiac disease
- •Age < 18 years and/or limited contractual capability
- •Addiction to alcohol, medical drugs or illegal drugs
- •Pregnant or breast-feeding women
- •Participation in another clinical trial
结局指标
主要结局
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
时间窗: Month 2
SV will be assessed using Echo Doppler Ao-VTI (Aortic velocity time integral). SZ will be measured in parallel using intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.
次要结局
- Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).(Month 2)