A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
研究概览
简要总结
Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).
The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.
The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.
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 (Participant, Investigator)
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
- •Clinical diagnosis of heart failure
- •Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
- •In sinus rhythm
- •Patients must have a telephone
- •Ability to give informed consent
- •Ability to complete the study
排除标准
- •Severe valve disease or previous valve replacement
- •Previous atrial flutter ablation
- •Chronic kidney disease Stage 3 or above
- •Recent myocardial infarction
- •Ongoing cardiac ischaemia
- •Infiltrative cardiomyopathy
- •Wolff-Parkinson White syndrome
- •Presence of second or third degree heart block
- •<90% biventricular pacing at 3 months
- •Hypertrophic cardiomyopathy
- •Pregnancy or breastfeeding
- •On treatment for hypothyroidism or hyperthyroidism
研究组 & 干预措施
Non-optimised
Standard atrioventricular delay
His-Ventricular (HV)-optimised
His-Ventricular (HV) optimised atrioventricular delay
干预措施: His-Ventricular (HV) optimisation (Other)
结局指标
主要结局
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
时间窗: 7 months and 11 months
次要结局
- Increase in 6-min walk test distance by ≥25 m(7 months and 11 months)
- ≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score(7 months and 11 months)
- Reduction of left ventricular end-diastolic volume.(7 months and 11 months)