NCT00758121终止不适用
CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 2
研究概览
简要总结
The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.
详细描述
The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.
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
- •Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
- •Respiratory Sensor programmed "On"
- •Classified as having NYHA Class III heart failure documented, in the past 12 months
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
排除标准
- •Inability or refusal to sign the patient Informed Consent
- •Inability or refusal to comply with the follow-up schedule
- •Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- •Patients prescribed to positive airway pressure therapy
- •A life expectancy of less than 180 days, per physician discretion
- •Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
- •Women who are pregnant or plan to become pregnant in the next twelve months
研究者
研究点 (2)
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