跳至主要内容
临床试验/NCT00858559
NCT00858559终止不适用

Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

Biotronik SE & Co. KG2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2009年3月最近更新:
适应症
干预措施

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

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

Active Comparator

Home Monitoring not used

干预措施: Standard implantable cardioverter defibrillator (Device)

1

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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