Home-Monitoring in ICD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 416
- 试验地点
- 13
- 主要终点
- Comparison of disease specific costs from a societal perspective.
研究概览
简要总结
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.
详细描述
Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer.
The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
- •Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines
排除标准
- •Age < 18 and > 80 years
- •Expected non-compliance
- •Known drug or alcohol abuse
- •Life expectancy < 1 year
- •NYHA classification IV
- •Participation in another clinical study
- •Participation in another telemonitoring concept
- •Pregnant or breast-feeding woman
- •Uncontrolled hypertension
- •No mobile phone use possible in patient residence
研究组 & 干预措施
Home-monitoring
Patients receive an additional home-monitoring (remote-monitoring) device (CardioMessengerII) following Biotronik Lumax ICD implantation. The device enables regular transmission and examination of ICD information via home-monitoring. Follow-up appointments in outpatient clinic are changed compared to standard care. While follow-up 1, 12, and 24 months after ICD implantation consist of outpatient clinic appointments, follow-up 3, 6, and 18 months after ICD implantation are conducted remotely.
干预措施: Home-monitoring provided by LUMAX ICD device and CardioMessenger II (Device)
Standard care
Patients randomised to the standard care group receive no home-monitoring device (CardioMessengerII) following Lumax ICD implantation. Patients have scheduled follow-up appointments at the ICD outpatient clinics at 1, 3, 6, 12, 18, and 24 months after ICD implantation.
结局指标
主要结局
Comparison of disease specific costs from a societal perspective.
时间窗: up to 24 months
次要结局
- Number of shocks(up to 24 months)
- Hospital admissions(up to 24 months)
- Cardiac events(up to 24 months)
- Quality of life(up to 24 months)
- Disease specific Costs from third party payers perspective(up 24 months)
- Overall costs from societal and third party payers perspective(up to 24 months)
研究者
F. Mueller-Riemenschneider
PD, Dr.
Charite University, Berlin, Germany