跳至主要内容
临床试验/NCT07020702
NCT07020702招募中不适用

ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

University Hospital, Bordeaux3 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年6月12日最近更新:
适应症
干预措施

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

Experimental

Patients implanted with an ICD

干预措施: Implantation of an ICD (Device)

Clinical follow-up

No Intervention

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)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验