British Randomised Controlled Trial of AV and VV Optimisation (BRAVO): Randomised Clinical Trial of the Effects of Non-invasive Haemodynamic Optimisation of Cardiac Resynchronisation Devices on Exercise Capacity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation
研究概览
简要总结
Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. The most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. However, this is not frequently performed because it is time consuming and requires two skilled operators. In this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger).
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Chronic heart failure due to systolic dysfunction
- •Biventricular pacemaker implanted
- •Give written informed consent
排除标准
- •Lung disease or any condition that would preclude them from walking on a treadmill
研究组 & 干预措施
Non-invasive haemodynamic optimisation
Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation
干预措施: Non-invasive haemodynamic optimisation (Other)
ECHO optimisation
Optimization of AV/VV delay using the guideline recommendations
干预措施: ECHO optimisation (Other)
结局指标
主要结局
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation
时间窗: 6 months following the last follow-up of the last patient
次要结局
- To determine whether pressure optimisation is at least equivalent to echo optimisation of flow: in terms resulting size of the heart in terms of quality of life scores in terms of blood marker of heart failure severity(6 months following the last follow-up of the last patient)