跳至主要内容
临床试验/NCT05539898
NCT05539898招募中不适用

Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias

Astrakhan Federal Centre For Cardiac Surgery2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2017年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
2
主要终点
Rate of VT primary occurrence

研究概览

简要总结

A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.

Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer)
  • NYHA II-IV
  • favorable prediction of survival for 1 year or more

排除标准

  • secondary SCD prevention
  • indications for open heart surgery
  • hypertrophic cardiomyopathy
  • arrhythmogenic right ventricular dysplasia
  • genetic channelopathies

结局指标

主要结局

Rate of VT primary occurrence

时间窗: 24 months

A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.

次要结局

  • Rate of Cardiac Mortality(24 months)
  • Number of Participants with CRT Response(24 months)

研究者

发起方
Astrakhan Federal Centre For Cardiac Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolay Ilov

Principal Investigator

Astrakhan Federal Centre For Cardiac Surgery

研究点 (2)

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