Reveal LINQ Respiration Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Demonstrating an agreement between LINQ and capnography derived respiratory rate
研究概览
简要总结
The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration data from patients undergoing a simulated 24-hour time period while being monitored with capnography.
详细描述
The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational, non-randomized, multi-center, clinical study. The study is expected to be conducted at up to 5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25 subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have a history of heart failure.
All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers. The expected duration of subject participation in the study (from start of study procedures to study exit) is approximately 1.5 hours. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 3 months.
All Adverse events will be collected throughout the study duration of a subject's participation in the study, beginning at the time of informed consent.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 55 years old
- •Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
- •Patient is willing and able to comply with the study procedures
- •Patient has an active Medtronic Reveal LINQ device that has been implanted for ≥ 60 days and no more than 3 years
排除标准
- •Patient has an existing condition that necessitates the use of supplemental oxygen
- •Patient has an active acute respiratory infection or a respiratory disorder that may affect ability to perform respiratory maneuvers
- •Patient has NYHA Class IV heart failure per most recent assessment
- •Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator
- •Patient is enrolled in another study that could confound the results of this study
- •Patient has an existing implantation of Medtronic IPG, ICD, CRT-D or CRT-P device
结局指标
主要结局
Demonstrating an agreement between LINQ and capnography derived respiratory rate
时间窗: 6 months
The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate.
次要结局
- Characterizing the agreement between LINQ and capnography derived respiratory rate(6 months)