Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Event-based Positive Predictive Value of breathing troubles
研究概览
简要总结
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
详细描述
The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 enrolled in the study must fulfil all of the following criteria:
- •Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
- •Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
- •Patients who provide signed and dated informed consent
排除标准
- •Inability to understand the purpose of the study or refusal to co-operate
- •Unavailability for scheduled follow-ups at the implanting centre
- •Already included in another clinical study that could affect the results of this study
- •Inability or refusal to provide informed consent
- •Patient is minor (less than 18-years old)
- •Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
- •Patient is forfeiture of freedom or under guardianship
研究组 & 干预措施
REPLY 200 implanted patients
REPLY 200 implanted patients
干预措施: REPLY 200 (Device)
结局指标
主要结局
Event-based Positive Predictive Value of breathing troubles
时间窗: 1 day
The Event-based Positive Predictive Value (PPV)of breathing troubles is complementary to Sensitivity. It is the proportion of abnormal events appropriately detected by SDB Monitoring function compared to the total number of abnormal events detected by SDB Monitoring function.
Event-based sensitivity of breathing troubles
时间窗: 1 day
Evaluation of this outcome requires measuring the number of ventilation pauses and ventilation reductions detected during the same night using SDB Monitoring function or the reference in-lab PSG (clinical assessment).
次要结局
- Safety based on Adverse events(3 months)
- Apnea Index-based Positive Predictive Value(1 day)
- Apnea Index-based Negative Predictive Value(1 day)