Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Significant adverse events, especially death, hospitalization, inadequate device therapies
研究概览
简要总结
Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician.
In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 a single-chamber implantable cardioverter-defibrillator (ICD)
排除标准
- •Contraindication for ICD
- •Indication for dual-chamber ICD or cardiac resynchronization therapy
研究组 & 干预措施
2
Home Monitoring not used
干预措施: Standard implantable cardioverter defibrillator (Device)
1
Home Monitoring
干预措施: Implantable cardioverter defibrillator with Home Monitoring function (Device)
结局指标
主要结局
Significant adverse events, especially death, hospitalization, inadequate device therapies
时间窗: 27 months
次要结局
- All-cause mortality(27 months)
- Number of device follow-ups(27 months)
- Quality of life(27 months)
