Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias
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
- 否
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
Nikolay Ilov
Principal Investigator
Astrakhan Federal Centre For Cardiac Surgery
