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临床试验/NCT03769272
NCT03769272Unknown不适用

Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting

Peter J Pugh0 个研究点目标入组 40 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle

研究概览

简要总结

Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart failure. It is a special pacemaker that consists of three pacing wires, which are implanted in the right upper and bottom chambers of the heart and via a vein on the surface of the main pumping chamber (left bottom chamber). CRT helps by improving co- ordination between the top and the bottom chambers of the heart. By stimulating the heart from the left and right bottom chambers, co-ordination can be restored and heart function as well as symptoms improve. It is known that up to 30-40% of patients of patients undergoing CRT pacemaker implantation do not attain any benefit. Given the inherent risks and costs of pacemaker implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.

It has been suggested that presence of scar tissue in the heart and suboptimal placement of the pacing wire on the top of the main pumping chamber can explain this poor response. The best place to position the pacing wire on the surface of the main pumping chamber is the area that contracts last and it can be identified using ultrasound scan of the heart.

Unfortunately, ultrasound is not always possible to help identifying the best area and only a minority of hospitals are able to use this method. Therefore we aim to investigate alternative ways of positioning the pacing wire in the best possible area of the main pumping heart chamber. Investigators propose to measure electrical signals as an alternative and more effective way in positioning the wire in the most effective area. Investigators aim to look at the relationship between the best area identified by ultrasound scan and by electrical signals and also use electrical signals to avoid areas of scar.

详细描述

Cardiac Resynchronisation Therapy (CRT) reduces both morbidity and mortality in selected patients with left ventricular dysfunction and intraventricular conduction delay who remain symptomatic despite optimal medical therapy.

It is known that up to 30% of patients of patients undergoing CRT implantation do not attain symptomatic benefit . Given the inherent risks and costs of device implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.

Factors associated with a poor outcome include presence of myocardial scar, and suboptimal Left Ventricular (LV) lead placement.

Pacing the LV at the most delayed LV region promotes contractile synchrony resulting in more effective and energetically efficient ejection, geometric remodelling with reduced LV end-systolic volume and improved cardiac function.

Studies using transthoracic echocardiographic (TTE) parameters to target the LV lead positioning have shown that an optimal LV lead position at the site of latest mechanical activation, avoiding low strain amplitude (scar), was associated with superior response to CRT and improved survival that persisted during follow-up.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • LV Ejection Fraction ≤ 35 %
  • New York Heart Association class I-IV
  • Left Bundle Branch Block
  • Male or female, aged 18 years or above
  • Able to give consent

排除标准

  • Patients with Atrial Fibrillation
  • Unable to give consent
  • Right Bundle Branch Block

结局指标

主要结局

Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle

时间窗: 1 day

The time from onset of depolarisation (Q wave) to sensed electrogram in the left ventricle ("LV") will be measured at various sites over the left ventricular epicardium to build up a map of myocardial electrical activation

次要结局

  • Mechanical activation of the left ventricle using echocardiography(1 day)

研究者

发起方
Peter J Pugh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter J Pugh

Consultant Cardiologist

Cambridge University Hospitals NHS Foundation Trust

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