Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
研究概览
简要总结
The purpose of the ReLINQuish study is to characterize the relationship between subcutaneous impedance and hemodynamic measurements in patients with heart failure. Additionally, the relationship between changes in subcutaneous impedance and other physiologic parameters during acute decompensated HF events will be characterized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients meeting at least 1 of 3 criteria will be included in the study:
- •Patients with symptomatic systolic or diastolic heart failure who in the clinician's judgment have a high likelihood of undergoing serial right heart catheterizations to aid in clinical management of their heart failure
- •Patients with dyspnea on exertion in whom exercise hemodynamics is indicated to diagnose diastolic dysfunction
- •Patients who have or will be implanted with a pulmonary artery pressure monitor
- •Patient is 18 years of age or older
- •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 protocol, including follow-up visits and Carelink transmissions.
排除标准
- •Patient has an existing Medtronic implantable cardiac device
- •Patient has a left ventricular assist device (LVAD)
- •Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
结局指标
主要结局
Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
时间窗: 18 months
The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Pulmonary Artery Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
时间窗: 18 months
The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
次要结局
- Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events.(18 months)
- Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events.(18 months)