NCT03590925Unknown不适用
Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Improvement of the quality of care in patients with ICM
研究概览
简要总结
The patients who undergo ICD(implantable cardioverter defibrillator) implantation for the primary prevention of sudden cardiac death with severe LV(left ventricle) dysfunction (ejection fraction ≤ 40%) by ICM(idiopathic cardiomyopathy).
Indications for ICD implantation for primary prevention in accordance with 2016 revised Korean indication guideline on ICD implantation
- FU LVEF(Left Ventricular Ejection Fraction) ≤ 30% (at least 40 days post-myocardial infarction)
- FU LVEF 31~35%, NYHA(the New York Heart Association) class II, III (at least 40 days post-myocardial infarction)
- FU LVEF ≤ 40%, NSVT(non-sustained ventricular tachycardia) (Holter), inducible VF(ventricular flutter) or sustained VT(ventricular tachycardia) at electrophysiological study (at least 40 days post-myocardial infarction)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Patients eligible for the indications for ICD implantation for primary prevention indication in accordance with 2016 revised Korean indication guideline on ICD implantation
- •Patients should be managed by non-EP physician
- •Patients who are willing to sign the informed consent
- •Patients who are willing to receive the implantation and post-operative follow-up
排除标准
- •Malignant tumor
- •Life expectancy < 12 months
- •Patients unable or unwilling to cooperate in the study procedures
结局指标
主要结局
Improvement of the quality of care in patients with ICM
时间窗: 3 years
the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device))
次要结局
- Improvement of the cardiovascular outcome of patients(3 years)
研究者
研究点 (1)
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