Predictive Risk Algorithm for Development of Right Ventricular Pacing Induced Cardiomyopathy - a Step Towards Personalized Pacemaker Lead Deployment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 试验地点
- 3
- 主要终点
- Primary aim
研究概览
简要总结
Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality. At present a lack of data leads to a failure to identify patients who are at risk of PICM and would benefit from pre-selection to physiological pacing. In the light of the foregoing, there is an urgent need for novel non-invasive detection techniques which would aid risk stratification, offer a better understanding of the prevalence and incidence of PICM in individuals with pacing devices and the contribution of additional risk factors.
详细描述
Retrospective review of patient characteristics including 12 lead resting electrocardiograms and imaging data (CMR, CT, echo, CXR and fluoroscopy of pacing leads) of patients with right sided ventricular pacing lead due to symptomatic bradycardia, who developed pacing induced cardiomyopathy (or need for CRT upgrade) versus patients who did not using supervised machine learning methods. Development of personalised predictive pacing algorithm to improve right ventricular lead placement, such as conduction system pacing or pre-emptive implantation of an additional left ventricular lead to prevent left ventricular dilatation and pacemaker-induced cardiomyopathy (PICM) with heart failure (left ventricular ejection fraction <50% by Simpson method), hospitalisation or death with the use of the retrospective patient data through machine learning.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •All patients who received a pacing device (VVI, DDD, ICD, leadless pacemaker) from the GSTT/RBH/KCH/ICH database in the last 10 years (from 01/01/2014)
- •All patients who are >18 years old.
- •Male and Female
排除标准
- •Patients who did not receive a pacing device (VVI, DDD, ICD, leadless pacemaker)
- •All patients <18 years old
- •Patients with congenital heart disease
- •Patients who have received artificial heart valves or underwent cardiac bypass surgery
- •Patients who did not have an echocardiogram after receiving a pacing device
结局指标
主要结局
Primary aim
时间窗: 2.5 years
Number of risk factors in participants who developed pacing induced cardiomyopathy
次要结局
- Tertiary aim(2.5 years)
- Quarternary aim(2.5 years)
- Quinary aim(2.5 years)
- Septenary aim(2.5 years)
- Secondary aim(2.5 years)
- Senary aims(2.5 years)