NCT02080000已完成不适用
Use of the R-wave to Optimise VV Delay in Heart Failure Patients Treated With Cardiac Resynchronisation Therapy
The Royal Bournemouth Hospital1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Quality of Life Score
研究概览
简要总结
The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. More specifically it is to investigate whether using the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function.
- •Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of <35% and either
- •a QRS duration of >150ms or
- •a QRS duration of 120 - 149ms with further evidence of dyssynchrony confirmed by echocardiography.
- •Participants must have >95% true biventricular pacing over the 1 month before enrolment and throughout the observation period.
- •The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of < 1mm or <20% of the total QRS deflection with standard LV offset settings applied.
- •The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing.
- •The participant must be willing to comply with the protocol requirements including travelling to the Royal Bournemouth Hospital for the attendances required for the study and intend to have their long term device follow up at the Royal Bournemouth Hospital at the time of enrolment.
- •Provision of informed consent
排除标准
- •Hypertrophic or restrictive cardiomyopathy
- •Suspected acute myocarditis
- •Correctable Valvulopathy
- •An Acute Coronary Syndrome within the last 3 months
- •Recent (within the last 3 months) or scheduled coronary revascularisation
- •Treatment resistant hypertension
- •Severe obstructive lung disease
- •Pregnancy at the time of enrolment or a desire to become pregnant during the study period
- •An inability to walk
- •Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
- •Unable to provide informed consent
研究组 & 干预措施
Optimised V-V timing delay
Experimental
V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG
干预措施: Optimisation of V-V timing using R wave on surface ECG (Other)
Standard V-V timing delay
Active Comparator
Standard settings
干预措施: Standard V-V timing settings (Other)
结局指标
主要结局
Quality of Life Score
时间窗: 3 months
次要结局
- Left Ventricular End Systolic Volume Index(3 months)
- 6 minute hall walk distance(3 months)
研究者
研究点 (1)
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