Clinical trial NCT04512703: Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Official title: Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrhythmia
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: -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.

Primary outcomes:
measure: Logistics of Study Device Setup and Monitoring
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Device Wear Time and Compliance
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Subject's Ability to Accurately Place Device
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Device Data Transmission and Device Connectivity
timeFrame: Period 1 and Period 2
measure: Ability to Provide Timely Arrythmia Monitoring
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Documentation of Clinically Actionable Events.
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Secondary outcomes:
measure: Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency
timeFrame: Period 1: Start of device wear at Day 0 to Day 7
measure: Association of Device Recordings to Clinical Events
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Device Recording Stability
timeFrame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
measure: Respiration Rate Front and Side Device Measurement Equivalency
timeFrame: Period 1: Start of device wear at Day 0 to Day 7
measure: Activity Front and Side Device Measurement Equivalency
timeFrame: Period 1: Start of device wear at Day 0 to Day 7
measure: Sleep Angle Front and Side Device Measurement Equivalency
timeFrame: Period 1: Start of device wear at Day 0 to Day 7
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Zoll Medical Corporation
name: Mike Osz
role: STUDY_DIRECTOR
References: