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临床试验/NCT04148703
NCT04148703进行中(未招募)不适用

Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
620
试验地点
2
主要终点
ICER (incremental cost effectivness ratio)

研究概览

简要总结

TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year follow-up.

详细描述

Professional practice guidelines recommend that pacemakers be followed with at least one to two in-office follow-ups per year, which is both a public health issue (the average time to get a consultation with a cardiologist being 42 days) but also an economic issue considering the number of patients implanted (Brignole EHJ 2013). Remote monitoring of pacemakers could allow an optimization of the long-term follow-up of pacemaker recipients in hospitals.

Compared to CRT and ICD, few studies have highlighted the economic advantage of remote monitoring with PM.

COMPAS study (Eur Heart J. 2012) demonstrated that remote monitoring is a safe alternative to conventional care over a 2 year-follow-up. This study also demonstrated that long-term remote monitoring of pacemakers decreased the number of ambulatory visits and enabled the early detection of important clinical and device-related adverse events.

As the study shows data up to 18 months, this is not sufficient to define the benefit of telecardiology in this population of patients.

SETAM study (Pacing Clin Electrophysiol 2017) demonstrated the benefit of remote monitoring showing an earlier diagnosis and management of atrial arrhythmias and a subsequently reduction of atrial fibrillation (AF) burden. The incidence and prevalence of AF is expected to increase with time, resulting in significant societal and economic impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single or dual chamber pacemaker implantation patients
  • patients agree to be enrolled in the study and followed during 4 years
  • patients have insurance coverage

排除标准

  • Minor patients
  • personn with disability
  • pregnant women
  • patient with life expectancy of less than 4 years

结局指标

主要结局

ICER (incremental cost effectivness ratio)

时间窗: 4 years

cost and medical consumtion collected with the French insurance care database

QALY

时间窗: 4 years

Quality Adjusted Life Years estimated by EQ5D-5L

次要结局

  • Safety of home monitoring(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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