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

Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Arrhythmia
• Intervention / Treatment: Device: µCor

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Medizinische Hochschule Hannover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.

Description

-Inclusion Criteria

The following criteria will be used to include subjects in phase I portion of the study:

• Healthy male and female volunteers.
• Subjects older than 21 years of age.
• Subjects willing to wear the µCor device for up to 30 days.
• Subjects willing to answer weekly phone calls from the study staff.

The following criteria will be used to include subjects in phase II portion of the study:

• Patients with a clinical indication for outpatient cardiac monitoring.
• Patients older than 21 years of age.
• Patients willing to wear the µCor device for up to 90 days.
• Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study period.
• Patients willing to answer weekly phone calls regarding their health status.
• 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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Group; Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.	Device: µCor; Sensor Monitor for arrhythmia and other bio-metric markers
Arrhythmia Monitoring Group; 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.	Device: µCor; Sensor Monitor for arrhythmia and other bio-metric markers
Front Position Devices; All devices placed in the front position
Side Position Devices; All devices placed in the side position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Period 1: Start of device wear at Day 0 to Day 7

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Mike Osz, Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): August 2, 2020
• Study Completion (ACTUAL): August 2, 2020

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Arrhythmias, Cardiac
• Other Study ID Numbers: 90D0167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes