Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5,000
- 试验地点
- 10
- 主要终点
- All-cause mortality
研究概览
简要总结
Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI;
- •LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
- •Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
- •Age ≥ 18 years; no upper age limitation.
排除标准
- •Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
- •Attempted VT / VF induction at electrophysiological study.
- •Need for a cardiac resynchronization therapy (CRT) device.
- •Enrollment in another interventional trial.
研究组 & 干预措施
1
干预措施: Optimized medical therapy (Drug)
2
干预措施: Implantable Cardioverter Defibrillator (Device)
结局指标
主要结局
All-cause mortality
时间窗: minimum 1 year follow-up (maximum 6 year)
次要结局
- 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications(minimum 1 year; maximum 6 years)