Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,501
- 试验地点
- 59
- 主要终点
- Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
研究概览
简要总结
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.
详细描述
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.
The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adults over 18,
- •First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention,
- •ICD with data-transmission features,
- •GSM mobile phone network at patient home compatible with remote transmission,
- •Patient able to use correctly the transmission system,
- •Patients having given a written informed consent.
排除标准
- •Class IV of NYHA,
- •Concomitant pathology leading to a life expectancy inferior to the protocol duration,
- •Concomitant participation to another protocol.
结局指标
主要结局
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
时间窗: 1 year
次要结局
- Time to onset of the first major cardiovascular event (censored criterion)(1 year)
- Death rate(1 year)
- Number of non programmed additional consultations at the implantation centre(1 year)
- Hospitalisation rate for a cardiovascular event(1 year)
- Cost-benefit analysis(1 year)
- Rate of unsuccessful or inappropriate ICD therapies(1 year)
- Mean costs of each follow-up strategy(1 year)
- Feasibility of the tele-follow-up in implantation centres(1 year)
- Number and cause of device re-programming(1 year)
- Number of drop-outs in the tele-follow-up group(1 year)
- Adherence of the patients to the tele-follow-up strategy(1 year)