Aquarius Pressure Variability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
研究概览
简要总结
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.
详细描述
This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).
This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.
The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.
The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
- •Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)
排除标准
- •Subject has a history of primary PAH
研究组 & 干预措施
All participants
All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)
干预措施: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. (Other)
结局指标
主要结局
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
时间窗: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Posture defined as lying left side down compared to baseline supine
次要结局
- Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.(Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement))
- Change in PAP During Change in Respiration(Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement))