Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)

Completed

Conditions: Heart Arrhythmia

Interventions: Device: µCor

Registration Number: NCT04512703

Lead Sponsor: Zoll Medical Corporation

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Group	µCor	Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.
Arrhythmia Monitoring Group	µCor	Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.

Primary Outcome Measures

Name	Time	Method
Subject's Ability to Accurately Place Device	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	Period 1 and Period 2	Count of subjects that had daily data transmission.
Documentation of Clinically Actionable Events.	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency	Period 1: Start of device wear at Day 0 to Day 7	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.
Sleep Angle Front and Side Device Measurement Equivalency	Period 1: Start of device wear at Day 0 to Day 7	Sleep angle was compared between front and side devices.
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 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.
Device Recording Stability	Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90	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.
Respiration Rate Front and Side Device Measurement Equivalency	Period 1: Start of device wear at Day 0 to Day 7	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.
Activity Front and Side Device Measurement Equivalency	Period 1: Start of device wear at Day 0 to Day 7	Activity counts were compared between front and side devices.