Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,327
- 试验地点
- 2
- 主要终点
- Evaluation for Equivalence of the Number of Patients Who Meet the Composite Safety Endpoint Between Home Monitoring Group(HM) and Control Group Which is HM + Conventional In-office Follow-up
研究概览
简要总结
The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.
The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.
详细描述
Patients will be randomized into HM follow-up only (Group 1) or HM & in-office follow-up (Group 2) and will be followed-up for 27 months.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated for IPG implantation under Japanese guidelines
- •Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
- •Able to utilize HM system throughout the study
- •Ability to give informed consent
- •Geographically stable and able to return for follow-ups for 27 months
- •Over 20 years old
- •Patient able to understand and follow the procedure stated in protocol
排除标准
- •Contraindicated for IPG under Japanese guidelines
- •Patients who are currently included in another cardiac clinical study
- •Patients with expected life period of less than two years
- •Patients who might undergo heart transplantation in next two years.
结局指标
主要结局
Evaluation for Equivalence of the Number of Patients Who Meet the Composite Safety Endpoint Between Home Monitoring Group(HM) and Control Group Which is HM + Conventional In-office Follow-up
时间窗: 2 years
The purpose of the primary endpoint is to compare the composite safety endpoint, Safety Event Rate (SER) which includes death, incidence of strokes and cardiovascular related serious adverse events requiring surgical interventions (e.g. device explants or lead revision) between HM Group and Control Group. Safety will be evaluated in the following testable hypothesis in an equivalence (non-inferiority) format: HØ: The safety event rate (SER) for a 24-month duration for Group 1 is not equivalent to the SER for Group 2. SER Group 1 - SER Group 2 ≥ Ha : The safety event rate (SER) for a 12-month duration for Group 1 is equivalent to the SER for Group 2 SER Group 1 - SER Group 2 \< Where, ( )represents the allowable clinically significant difference. 5% was set for the study. A rejection of the null hypothesis (HØ) will indicate that the safety event rate for Group 1 is equivalent (non-inferior) to that of Group 2.
次要结局
- The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year(2 years)
- Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year(2 years)