EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- NSVT
研究概览
简要总结
Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will provide data on cardiac rhythm over a period of 18 months. This will provide an extended monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care. Therefore, detection of arrhythmias could be used in risk stratification and decision-making with regard to offer an implantable defibrillator and anticoagulants.
详细描述
Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients smart phone and monitored for 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertrophic cardiomyopathy
排除标准
- •aortic stenosis (moderate, severe)
- •hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and syndromes (e.g. Noonan)
- •systolic heart failure
- •cardiac device (previous pacemaker, implantable defibrillator )
- •history of myocardial infarction
- •percutaneous coronary intervention and/or coronary artery by-pass grafting
- •pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic atrial tachycardia ablation
- •renal clearance below 40
- •malignancy or other comorbidity with less than five years life expectancy
- •pregnancy of planned within 18 months
- •drug addiction, severe mental disease
- •not able to participate in 18 months follow-up
- •5 years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.
研究组 & 干预措施
Insertable cardiac monitor
All patients will undergo monitoring using an insertable cardiac monitor (single arm)
干预措施: Insertable cardiac monitor (Device)
结局指标
主要结局
NSVT
时间窗: 18 months
Incidence of non-sustained ventricular tachycardia (NSVT)
次要结局
- AF(18 months)