Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.
详细描述
Patients (n=70) with long-term (>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
- •Willing and able to give informed consent for the intervention
排除标准
- •Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
- •Patients with complete heart block and no reprogramming options
研究组 & 干预措施
Usual Care
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
Personalised programming
Patient will have tailored pacemaker programming based on echocardiographic findings, blood results, and symptoms in an attempt to minimise right ventricular pacing and extend battery longevity.
干预措施: Personalised programming (Device)
结局指标
主要结局
Left ventricular ejection fraction
时间窗: 6 months
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
次要结局
- Battery Longevity(6 months)
- Quality of Life Measures(6 months)
- LV remodelling parameters(6 months)
研究者
KK Witte
Senior Lecturer in Cardiology
University of Leeds