Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Acute electrical measurements
研究概览
简要总结
The aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.These modalities include biventricular pacing and conduction system pacing utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological form of pacing. The study hypothesises that this will produce more effective cardiac resynchronisation.
详细描述
This is a single centre acute electrical/haemodynamic and observational study of a subgroup of patients with heart failure. A total of 60 will be recruited. The acute study involves within patient comparison of biventricular and conduction system pacing using detailed electrical mapping and high precision haemodynamic measurement protocol.
Participants will have permanent conduction system pacing if;
- Baseline left bundle branch block and QRS > 140ms or QRS >150ms and any QRS morphology AND
- Conduction system pacing is successful at reducing QRS duration by 20ms or more with satisfactory pacing parameters.
Participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3 months, 6 months and 12 months. Non-invasive markers including mechanical activation pattern (echocardiography and cardiac MRI) and electrical activation pattern (ultra-high frequency electrocardiography) will be used to identify the characteristics of patients who benefit from conduction system pacing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for conventional CRT
- •Severe heart failure (LVEF, a measure of heart pumping, < 35% - severe)
- •Prolonged QRS duration (>120ms)
- •Adults willing to take part (age > 18 years)
- •Able to give consent
排除标准
- •Unable to give consent
- •Children (age < 18 years)
- •Pregnant women
结局指标
主要结局
Acute electrical measurements
时间窗: 20 minutes
Mean change in left ventricular activation time (Milliseconds) (measured using ECGI) during AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in Milliseconds.
Acute change is systolic blood pressure
时间窗: 20 minutes
Mean change in systolic blood pressure (mmHg) from atrial pacing to AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in mmHg.
次要结局
- Conduction system battery longevity(6 weeks, 3 months, 6 months, 12 months.)
- Conduction system lead threshold(6 weeks, 3 months, 6 months, 12 months.)
- Left ventricular ejection fraction(12 months)
- Cardiopulmonary exercise testing(6 months)
- Heart failure symptoms(6 months)