Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 73
- 主要终点
- Mortality
研究概览
简要总结
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.
This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.
详细描述
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.
This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.
After standard ICD implantation procedure, the following steps are performed at the pre-discharge follow-up:
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Programming: VR-T: VVI 40 ppm, Onset 20%, Stability 20 ms
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DR-T: DDD 50-60 ppm, activation of IRSplus and SMART
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HF-T: DDD-BiV 50-60 ppm, achieve at least 85% biventricular resynchronisation, activation of SMART
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All devices: VT zone as therapy zone, VF zone. Programming recommendations for VT/VF zones to standardize treatment:
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VF zone: 200-250 bpm/ 300-240 ms, ATPoneshot ON
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VT1 zone: 167-200 bpm/ 360-300 ms, ATP ON
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VT2 zone: 120-167 bpm/ 500-360 ms, ATP ON
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Activation of Home Monitoring (HM) and online registration for HM service
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for ICD implantation according to MADIT-II:
- •Myocardial infarction 30 days or more before implantation
- •LVEF of 30% or less within 3 months before implantation
- •Angiography within the preceding 12 months
- •The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent
排除标准
- •Patients with contraindication for ICD implantation
- •Conventional ICD indication (i.e. other than MADIT-II)
- •Myocardial infarction within the past 30 days
- •Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)
- •NYHA functional class IV
- •Unexplained syncope within 3 years
- •Advanced cerebrovascular disease
- •Life expectancy very probably below 12 months
- •Pregnant or breast-feeding women
- •Age < 18 years
- •Patients who are already enrolled in another study (therapy/intervention phase)
结局指标
主要结局
Mortality
时间窗: 12 months
次要结局
- Non-sudden cardiac death(12 months)
- Sudden cardiac death(12 months)
- Risk of 1st heart failure hospitalization(12 months)
- No. of delivered ICD therapies(12 months)
- No. of VT Storms (> 3 VT/24h)(12 months)