Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
- 试验地点
- 64
- 主要终点
- Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
研究概览
简要总结
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
详细描述
This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is strongly recommended that a patient have a diagnostic PSG within 12 months of the expected implant date documenting moderate to severe CSA.
- •Age 18 years or older
- •Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
- •In the opinion of the investigator, subject is willing and able to comply with the protocol.
- •Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- •In the opinion of the Investigator, life expectancy exceeds one year.
- •The subject is not pregnant or planning to become pregnant.
排除标准
- 未提供
结局指标
主要结局
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
时间窗: 5 years
Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
时间窗: 12 months
Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation \<90%
次要结局
- Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy(5 years)
- Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy(36 and 60 months)