INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 34
- 主要终点
- Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
研究概览
简要总结
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).
The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.
All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals
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
- •Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
- •Written informed consent
- •Ejection Fraction <= 35%
- •New York Heart Association (NYHA) Class I-III
- •Age >=18 and <=80 years
- •In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available
排除标准
- •Arterio ventricular (AV) Block III / AV Block II Type Mobitz
- •Severe renal insufficiency
- •Coronary angiology intervention within previous 3 months
- •Myocardial infarction within previous month
- •Life expectancy < 1 year
- •Expected poor data quality / compliance
- •Pregnancy
- •Patient is already participating to another study with active therapy arm
研究组 & 干预措施
Group A
Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
干预措施: Quarterly remote follow ups and remote monitoring (Other)
Group B1
Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
干预措施: Quarterly remote follow ups + additional phone calls and remote monitoring (Other)
Group B2
Personal ICD/CRTD follow up (Quarterly visits)
干预措施: Quarterly in clinic follow ups and remote monitoring (Other)
结局指标
主要结局
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
时间窗: 12 months (between 1 and 13 months post implant)
次要结局
- Number of follow ups with relevant findings(12 months (between 1 and 13 months post implant))
- Mortality(12 months (between 1 and 13 months post implant))
- Heart failure hospitalizations(12 months (between 1 and 13 months post implant))
- Cardiovascular events(12 months (between 1 and 13 months post implant))
- Number of additional, unscheduled follow ups(12 months (between 1 and 13 months post implant))
- Number of delivered / appropriate ICD therapies(12 months (between 1 and 13 months post implant))
- Quality of life (MLHFQ)(12 months (between 1 and 13 months post implant))