Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Subject's Ability to Accurately Place Device
研究概览
简要总结
Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe. Health adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.
To observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System (µCor system ) that non-invasively captures thoracic fluid content, electrocardiogram, heart rate, respiratory rate, activity, and body posture. tory outpatient cardiac monitoring.
详细描述
The study will consist of two phases. Phase I of the study will enroll 6 healthy volunteers, who have no indication for remote cardiac monitoring. Subjects are required to participate in the study for 30 days.
Phase II of the study will enroll up to 44 patients indicated for outpatient cardiac monitoring and will participate in the study for up to 90 days.
All subjects will wear the device in two locations, one along the left midaxillary line and the other along the left midclavicular line for the first seven days.
Thereafter, for the remainder of the study, half the enrolled subjects will only wear the device in the left midclavicular position and the other half will wear the device in the left midaxillary position. Subjects will use a diary to keep a daily log their activities of daily living (phase I) or a log of any symptoms related to heart rhythm abnormalities and heart failure (phase II).
Data will be acquired with the µCor system and wirelessly transmitted daily to a remote server for processing, generating thoracic fluid content, ECG, heart rate, respiration rate, activity, and posture measurements. Investigators will have access only to ECG data.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •The following criteria will be used to exclude subjects from phases I and II portions of the study:
- •Subjects reporting or planning to be pregnant.
- •Subjects with any cardiac implantable electronic devices, including loop recorders.
- •Subjects with a wearable cardioverter defibrillator.
- •Subjects with Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices.
- •Subjects with any skin condition that would prevent them from wearing the µCor system.
- •Subjects who are non-ambulatory.
- •Subjects without adequate cellular transmission access that would prevent data download from the µCor device.
- •Subjects participating in another clinical study.
- •Subjects unable to give informed consent.
- •Employees of ZOLL or their family members.
- •Subjects traveling during the study participation period that prevents planned office visits and weekly phone calls from the study coordinator.
- •Subjects expected to undergo a planned MRI exam during the participation period.
结局指标
主要结局
Subject's Ability to Accurately Place Device
时间窗: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Device Data Transmission and Device Connectivity
时间窗: Period 1 and Period 2
Count of subjects that had daily data transmission.
Documentation of Clinically Actionable Events.
时间窗: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Logistics of Study Device Setup and Monitoring
时间窗: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup
Device Wear Time and Compliance
时间窗: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Ability to Provide Timely Arrythmia Monitoring
时间窗: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
次要结局
- Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency(Period 1: Start of device wear at Day 0 to Day 7)
- Sleep Angle Front and Side Device Measurement Equivalency(Period 1: Start of device wear at Day 0 to Day 7)
- Association of Device Recordings to Clinical Events(Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90)
- Device Recording Stability(Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90)
- Respiration Rate Front and Side Device Measurement Equivalency(Period 1: Start of device wear at Day 0 to Day 7)
- Activity Front and Side Device Measurement Equivalency(Period 1: Start of device wear at Day 0 to Day 7)