ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Occurrence of major rhythmic events
研究概览
简要总结
EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) <50% and risk factors of ventricular arrhythmia, otherwise not considered for implantation of an implantable cardioverter defibrillator (ICD).
The objective is to assess the effectiveness of a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation.
详细描述
Responsible for 10% of deaths in the general population, sudden cardiac death is mostly caused by malignant ventricular arrhythmias (80%). These arrhythmias mainly occur in cardiomyopathies (75-90%). Currently, the prevention of sudden death is based on risk stratification according to the evaluation of myocardial contractility with indications for prophylactic ICD implantation reserved for LVEF ≤ 35%. This predictor is notoriously insufficient for several main reasons: 1) While ICDs are indicated in patients with LVEF ≤35%, only a minority (2 -5% per year) will suffer from arrhythmia and therefore benefits from ICD implantation, while all will be subject to potential complications. 2) The majority of sudden death (70-80%) occur in patients with LVEF >35%; while they have a lower arrhythmia risk (1-2% per year), they constitute a population four times larger, which is not stratified. 3) Finally, the cardiomyopathy population is broad, and include distinct clinical scenarios that are not specifically addressed.
While conventional electrophysiological studies only boast a limited number of measurements, the proposed strategy is a detailed electrophysiological characterization of the altered ventricle. Measurements include a detailed mapping of the left ventricle in the basal state and during extrastimuli, and programmed stimulation of the right and left ventricle including the simultaneous recording of the Purkinje system.
Follow-up will be performed for 3 years, looking for the occurrence of major arrhythmic events such as: 1) Appropriate therapy (for VT/VF) delivered by an ICD or 2) documented ventricular arrhythmia on ECG, implantable loop recorder or pacemaker or 3) Clinical sudden death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cardiomyopathy with 35%<LVEF<50% and at least one risk factor
- •Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation
排除标准
- •Patients who are minors or aged 80 or over
- •Patients with unstable coronary artery disease
- •Myocardial infarction less than 40 days old
- •Coronary revascularisation <90 days
- •Patients with intracardiac thrombus
- •Patients with a mechanical heart valve
- •Patient implanted with an automatic defibrillator
- •Patient life expectancy <1 year
- •Pregnant or breast-feeding women
- •Anti-arrhythmic drugs other than beta-blockers and amiodarone
研究组 & 干预措施
Implantation of an ICD
Patients implanted with an ICD
干预措施: Implantation of an ICD (Device)
Clinical follow-up
Patients not implanted with an ICD
结局指标
主要结局
Occurrence of major rhythmic events
时间窗: 60 months
Follow-up on Occurrence of major rhythmic events
次要结局
- Spatial distributions of abnormal ventricular potentials(Day 1)
- Surfaces distributions of abnormal ventricular potentials(Day 1)
- Purkinje potentials in induced arrhythmias(Day 1)
