Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,140
- 试验地点
- 2
- 主要终点
- Major adverse event, including death from any cause, cardiovascular, and procedure- or device-related MAE.
研究概览
简要总结
Remote monitoring is now universally available for all cardiac implantable electronic devices (CIEDs), and it has become the standard of care for the management of patients with these devices. In many countries, it is being proven that patients with implantable defibrillator (ICD) or cardiac resynchronizing therapy (CRT) can benefit from remote monitoring (RM) both economically and clinically. From previous RM related clinical studies, it is reasonably accepted that hospitalization cost and mortality rate is comparably higher in defibrillator patients compared to pacemaker indicated patients.
However, it is yet to be discovered which group of defibrillator patients are the most beneficiaries using remote monitoring system. In this study, the investigators would further categorize defibrillator patients into different indication subgroups and compare both economic and clinical benefits among different indication. By comparing economic and clinical benefits of remote monitoring by different subgroups, the investigators might be able to set a guideline on which group of patients should be strongly suggested for remote monitoring utilization.
Therefore, the investigators perform a prospective study in Korean population to compare economic and clinical benefits of RM compared to conventional follow-up in overall study cohort and by different subgroups. (ICD & CRT-D).
详细描述
The investigators propose to prospectively recruit 556 patients with ICD or CRT-D implantation in 10 sites in Korea.
- Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group.
- In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
- In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ICD and CRT-D patients who are over the age of 18
- •Ability to provide informed consent and to complete the study and required follow-up
排除标准
- •Those who refuse to participate in the trial.
- •Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
- •Patient who refuse to use or expected to use less than 75% of remote monitoring system.
结局指标
主要结局
Major adverse event, including death from any cause, cardiovascular, and procedure- or device-related MAE.
时间窗: up to 2 years
Definition of device-related adverse events 1. delivery of ≥1 inappropriate shock(s); 2. delivery of ≥2 symptomatic inappropriate ATP; 3. symptomatic defibrillator-mediated tachycardia; 4. infection or extrusion of the ICD; 5. ineffective pacing; 6. intermittent or permanent undersensing; 7. clinical phrenic stimulation; and 8. lead or pulse generator dysfunction.
Major adverse event
时间窗: up to 2 years
Definition of major adverse events (MAE) 1. fatal or life-threatening 2. prompted or prolonged a hospitalization; 3. caused major or permanent disability or injury; 4. required an intervention to prevent permanent disability or injury
次要结局
- Economic benefit by remote monitoring(up to 2 years)
- Economic benefit by remotemonitoring(up to 2 years)