Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- At least one unnecessary consultation during two years of follow-up
研究概览
简要总结
Follow-up strategy for patients implanted with a pacemaker.
详细描述
This study seeks to verify that a follow-up strategy for patients implanted with a mono- or double-chamber pacemaker, stimuli-dependent or not, for 2 years, by means of data transmissions of the devices by Carelink Express during the usual consultations with the treating cardiologist significantly reduces the number of unnecessary consultations in the implant centers (without any change in treatment or pacemaker programming) compared to the usual follow-up mode recommended for this type of device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Any patient implanted with a Medtronic brand AAI (R), VVI (R) and DDD (R) cardiac pacemaker, allowing transmission via Carelink Express (Medtronic)
- •and accepting inclusion in the study.
- •The patient should be followed by a city cardiologist participating in the study.
排除标准
- •Age <18 years
- •Pregnant or likely to become pregnant during the study
- •Patient with an unstable medical condition, NYHA Class IV Heart Failure
- •Presence of psychiatric illness, depression, anxiety disorder
- •Presence of diseases, other than heart disease, responsible for a reduction in life expectancy for the duration of the study.
- •Patient unable to follow protocol (respond to questionnaires)
- •Change of residence planned during the study
- •Participation in an interventional and therapeutic clinical study; Patient participation in an observational study is permitted.
- •Patient not signed consent form
- •Patient under legal protection
结局指标
主要结局
At least one unnecessary consultation during two years of follow-up
时间窗: 2 years
The primary outcome measure will be at least one unnecessary consultation during two years of follow-up (apart from the first mandatory consultation in all patients)
次要结局
- Occurrence of a serious adverse event(2 years)
- In-depth sociological study carried out through questionnaires and individual interviews(2 years)
- Quality of life(2 years)
- The medical economic evaluation to measure the efficiency of the device Carelink Express allowing patients' tele-monitoring implanted by a pacemaker(2 years)