Dual Site Left Endocardial Pacing for Cardiac Resynchronisation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acute Haemodynamic Response to Dual Left Ventricular Pacing
研究概览
简要总结
We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling.
Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. CRT requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. These two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function.
The investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside.
The investigators wish to assess whether:
- Using two wires within the left side of the heart gives a greater increase in heart function than one.
- It is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat.
- Is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? They are investigating this in people with hearts that beat less effectively than normal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 60 years or above.
- •Having a suitable Atrial Fibrillation/flutter or Ventricular Tachycardia ablation procedure
- •Evidence of abnormal Left Ventricular structure and function, as shown by Left Ventricular ejection fraction of less than 40%
排除标准
- •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 to Dual Left Ventricular Pacing
时间窗: Mean of multiple recordings in each patient as detailed above
Acute haemodynamic response to pacing (change in Left Ventricular dP/dt max) between dual site Left Ventricular pacing and biventricular pacing Pacing protocols were performed with a baseline of 30 seconds of right ventricular pacing followed by two 30-second test configurations, and then a further baseline. The pacing configurations were tested, in a randomized order, 3 times each. Electrophysiology catheters were positioned at the right ventricular mid septum for baseline pacing, and at the left ventricular septum and at the left ventricular lateral wall, at the site of latest electrical activation i identified from a left ventricular electrical activation map This provided two single-site left ventricular pacing configurations, which could be combined to allow right ventricular and left ventricular lateral (Biventricular pacing) and left ventricular septal and left ventricular lateral (dual left ventricular pacing)
次要结局
未报告次要终点
研究者
Dr James Gamble
Research Fellow
Oxford University Hospitals NHS Trust