Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation
研究概览
简要总结
The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology
详细描述
Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations.
After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.
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 after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software
- •left bundle branch block before CRT implantation
- •PQ interval ≤ 250 ms before implantation
排除标准
- •high-grade AV block
- •any contraindication concerning a safe CMR performance including claustrophobia
- •terminal heart failure (NYHA IV) or cardiac decompensation
- •life expectancy < 1 year
- •women with child-bearing potential, pregnancy
- •drug abusus
结局指标
主要结局
Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation
时间窗: The measurements will be done at Day 1
The activation time will be measured in 16 different device programming settings
次要结局
未报告次要终点