The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
研究概览
简要总结
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.
详细描述
The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has developed a battery-powered implantable device that treats central sleep apnea. The device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. This combination is called the remedē® system.
The aim of this study is
- to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea
- to collect safety information of all patients diagnosed with central sleep apnea
- to obtain additional short and lang term information on the safety and performance of the remedē® system, including an evaluation if there's an impact on the quality of life of patients treated with the the remedē® system in daily practice.
The information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately.
Approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in Europe. For this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All patients screened for sleep disordered breathing
- •Age > 18 years
- •Signed Ethics Committee approved informed consent
- •Implant Inclusion criteria
- •Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system
排除标准
- •Patients meeting the criteria as referred to in the latest version of the implant manual
结局指标
主要结局
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
时间窗: From implant up to 5 years (collected until 24 month FU)
Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
次要结局
- Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline(12 months post-implant)
- Impact on Quality of Life Compared to Baseline(Up to 5 years post-implant)
- Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline(12 months post implant)
- Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea(Up to 2 years (collected until 6M FU))