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.
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. Study staff will make weekly phone calls to subjects and record any new clinically actionable events. Patients will have monthly office visits. At the end of 30 days (phase I) or 90 days (phase II), patients will end wear and will complete the study follow-up questionnaire. The study will enroll a maximum of 50 subjects. Six healthy volunteers will be enrolled for phase I of the study. Remaining 44 subjects will be enrolled for phase II and will have an indication of outpatient cardiac monitoring.
Study Type
OBSERVATIONAL
Enrollment
51
Sensor Monitor for arrhythmia and other bio-metric markers
Medizinische Hochschule Hannover
Hanover, Germany
Logistics of Study Device Setup and Monitoring
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
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Device Wear Time and Compliance
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.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Subject's Ability to Accurately Place Device
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.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Device Data Transmission and Device Connectivity
Count of subjects that had daily data transmission.
Time frame: Period 1 and Period 2
Ability to Provide Timely Arrythmia Monitoring
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.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Documentation of Clinically Actionable Events.
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.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency
The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Association of Device Recordings to Clinical Events
Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Device Recording Stability
Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: 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
Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Activity Front and Side Device Measurement Equivalency
Activity counts were compared between front and side devices.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Sleep Angle Front and Side Device Measurement Equivalency
Sleep angle was compared between front and side devices.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.