Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline in bioimpedance measurement at 4 weeks
研究概览
简要总结
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
详细描述
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.
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
- •has an CardioMEMs device implanted
- •has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
- •is able to give informed consent
排除标准
- •has pacemaker/ICD
- •is pregnant or breastfeeding
- •is an amputee
- •has been diagnosed with multiple medical conditions that would make participation burdensome
- •not able to co-operate with impedance measurements
结局指标
主要结局
Change from baseline in bioimpedance measurement at 4 weeks
时间窗: Baseline and 4 weeks
Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures
次要结局
未报告次要终点