Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 3P-MACE
研究概览
简要总结
This is a prospective, non-interventional cohort study. It tests the hypothesis that
- Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome.
- Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients.
- Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and/or device-detected sleep apnea.
- Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and/or device-detected sleep apnea.
- Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes.
- Burden / variation of device-detected sleep apnea and/or device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.
详细描述
All forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
- •signed informed consent
排除标准
- •any contraindication to perform a cardiac CT examination
- •eGFR < 30 ml/min/1.73 m2
- •allergy against CT contrast medium
- •hyperthyreoism
- •inability of the patient to understand the study purpose and plan
- •inability of the patient to perform baseline examinations
- •pregnancy or breast-feeding; women with childbearing potential
- •estimated life expectancy below one year
研究组 & 干预措施
patients with severe sleep apnea
defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment
patients with autonomic imbalance
defined by PRD ≥ 5.75deg2 (native) and/or ≥ 3 deg2 (paced) assessed within the first 12 months of enrollment
patients with a sedentary lifestyle
defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment
结局指标
主要结局
3P-MACE
时间窗: time to first event, follow up for 120 months
death, myocardial infarction and/or stroke
device-detected atrial fibrillation
时间窗: time to first event, follow up for 120 months
first episode lasting more than 6 minutes or 24 hours
device-detected atrial fibrillation
时间窗: after 1, 3, 5 years
total burden
device-detected sleep apnea
时间窗: after 1, 3, 5 years
severity (RDI \< versus \> 20/h)
次要结局
- Deterioration of lung function(after 5 years)
- QoL assessment(after 5 years)
- Progression of subclinical peripheral artery disease(after 5 years)
- incidence of common opthalmological disease(assessed within the first year after study enrollment)