REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,104
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.
详细描述
REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •All patients implanted with an ICD as for standard indications
- •Over 18 years of age
- •Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
排除标准
- •Subject who is, or is expected to be inaccessible for follow-up
- •pregnancy
结局指标
主要结局
Effectiveness
时间窗: 12 months
The effectiveness based on the comparison between the App monitoring and the traditional remote control will be assessed through the following endpoints: • Percentage of time (days) with an active connection between device and the transmitter/smartphone app
Adherence
时间窗: 12 months
The adherence will be measured through the following endpoints: • Compliance with RM quantified as percentage of patients who registered with the smartphone App
次要结局
- Clinical benefits in CRT area:(12 Months)
- Clinical benefits in ICD therapies(12 months)
研究者
Antonio Rapacciuolo
Principal Investigator
Federico II University