Crome/Cobalt Respiration Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Respiration Rates Comparison (Activities Representative of Nightly Average)
研究概览
简要总结
The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder).
详细描述
This study will enroll subjects who have already received a Medtronic Crome or Cobalt ICD or CRT-D MRI SureScan device and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will be asked to complete various breathing/exercise activities while connected to a capnography monitor and a Holter recorder and respiration rates from both devices will be compared for accuracy, with the capnography monitor being the source of truth.
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
- •Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system which has been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT)
- •Subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by Medtronic:
- •Model 6946M
- •Model 6947
- •Model 6947M
- •Model 6935
- •Model 6935M
- •Subject is ≥ 18 years of age
- •Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
- •Subject is willing and able to comply with study procedures
排除标准
- •Subject has existing condition that necessitates the use of supplemental oxygen
- •Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
- •Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
- •Subject has an active or suspected lead integrity issue, in the opinion of the investigator
- •Subject is enrolled in another study that could confound the results of this study
- •Subject has NYHA Class IV heart failure
结局指标
主要结局
Respiration Rates Comparison (Activities Representative of Nightly Average)
时间窗: During In-clinic Testing Visit, an average of 2 hours
Difference between the daily respiration rate determined using capnography and the daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Daily Capnography Respiration Rate
时间窗: During In-clinic Testing Visit, an average of 2 hours
Daily respiration rates will be calculated using a series of paired device-derived respiration rates and capnography waveform-derived respiration rates, where the capnography respiration rate will be the source of truth. The differences in these daily respiration rates will be evaluated to determine whether the daily device-derived respiration rate accuracy is acceptable (i.e., consistently within +/- 3 breaths per minute of the true respiration rate).
Daily Device-derived Respiration Rate
时间窗: During In-clinic Testing Visit, an average of 2 hours
Daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Difference in Respiration Rate
时间窗: During In-clinic Testing Visit, an average of 2 hours
Difference between the daily respiration rate determined using capnography and the daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
次要结局
未报告次要终点