Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 163
- 试验地点
- 26
- 主要终点
- Days Lost
研究概览
简要总结
EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup and AF.
详细描述
EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation as well as the early optimization of cardiac resynchronization therapy via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator backup (CRT-ICD) and paroxysmal or persistent AF.
300 patients with a documented history of AF will be enrolled and randomized 1:1 to standard patient management or AF management and early optimization of CRT via Home Monitoring. The patient outcome regarding days lost due to cardiovascular mortality, cardiovascular hospitalization and inappropriate ICD therapy will be documented during an observational period of 1 year.
Another 300 patients undergoing CRT-ICD implantation without a history of AF will undergo an AF evaluation during the first three months of CRT. If a patient shows an AF episode during this period, he is eligible for study inclusion. If no AF episode occurs during AF evaluation, the patient be treated as screening failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No Masking.
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 CRT with ICD-backup
- •Paroxysmal or persistent AF
- •Optimized HF-related medication
排除标准
- •Permanent AF
- •Contraindication for anticoagulation
- •Stroke within the last 6 weeks
- •Acute coronary syndrome within the last 2 months
- •Cardiac surgery within the last 2 months
- •Acute myocarditis
- •Severe chronic obstructive pulmonary disease (COPD)
- •Planned cardiac surgery or interventional measures within the coming 3 months
- •Dialysis dependency
- •Life expectancy < 12 months
- •Insufficient GSM (Global System for Mobile Communication)/GPRS (General Packet Radio Service)-network coverage
- •Previously implanted unipolar right atrial lead
- •Previously implanted right atrial lead with tip-ring distance > 11 mm
结局指标
主要结局
Days Lost
时间窗: 12 months
Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.
次要结局
- Progression of AF and AT/AF Burden(12 months)
- Heart Failure Clinical Composite Score (Packer Score)(12 months)
- Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)(12 months)