Intracardiac Haemo-dynamics and Echocardiographic Assessment to Optimise Lead Placement for CRT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Acute haemodynamic response in area of latest mechanical activation and another vein
研究概览
简要总结
Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT.
Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information.
The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed.
This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •With ejection fraction <35%
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Indication for cardiac resynchronisation therapy
排除标准
- •Left Ventricular Ejection Fraction >35%
- •Severe peripheral vascular disease (that would make arterial access more risky)
- •Haemodynamic instability (such that a longer procedure is inadvisable)
结局指标
主要结局
Acute haemodynamic response in area of latest mechanical activation and another vein
时间窗: Time 0 (during implant procedure)
To assess whether pacing at the site of latest mechanical activation produces the maximal acute haemodynamic response to biventricular pacing, when compared to other attainable Left Ventricular coronary venous pacing sites. Acute haemodynamic response measured as percentage change in left ventricular dP/dt max (maximum rate of change of left ventricular pressure) recorded by a left ventricular pressure wire, between baseline atrial pacing at 80 beats per minute and biventricular pacing in each vein
次要结局
- Area of latest mechanical activation in right ventricular pacing and intrinsic rhythm(1 day post procedure)
- Maximum acute haemodynamic response between all available pacing vectors in the vein within the area of latest mechanical response(Time 0 (during implant procedure))
- Acute haemodynamic response by NICOM and pressure wire(Time 0 (during implant procedure))
研究者
Dr James Gamble
Co-investigator
Oxford University Hospitals NHS Trust
