Heart ArrhythmiaPATCHNCT04512703

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

An observational study of Heart Arrhythmia, run by Zoll Medical Corporation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Heart Arrhythmia
What is being tested?: µCor
Type of treatment: Medical device
How many people: 51 participants
Where: 1 siteGermany
Study dates: 25 Oct 2018to 2 Aug 2020
How long will I take part?: 90 Days
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Medizinische Hochschule Hannover
Hanover

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions: Heart Arrhythmia
Being tested: µCor
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

µCorDevice
Sensor Monitor for arrhythmia and other bio-metric markers

Study groups in NCT04512703
Study group	Role	What they receive
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. Receives: Device: µCor
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. Receives: Device: µCor
Front Position Devices		All devices placed in the front position
Side Position Devices		All devices placed in the side position

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Period 1: Start of device wear at Day 0 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 20182 Aug 2020

First posted13 Aug 2020
Study start25 Oct 2018
Primary completion2 Aug 2020
Study completion2 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 51 participants (actual)
Target duration: 90 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT04512703
Sponsor's protocol ID: 90D0167
Acronym: PATCH
Status last verified: Jun 2021
First submitted: 31 Jul 2020
Last updated: 3 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study
ClinicalTrials.gov ID: NCT04512703
Acronym / sponsor ID: PATCH / 90D0167
Conditions: Heart Arrhythmia
Study type: Observational
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Zoll Medical CorporationIndustry (pharma, biotech, devices)
Study start: 25 Oct 2018 (actual)
Primary completion: 2 Aug 2020 (actual)
Study completion: 2 Aug 2020 (actual)
First posted: 13 Aug 2020 (actual)
Results: Posted 3 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 90 Days
Number of arms: 4

Arm	Type	Receives
Healthy Group	–	Device: µCorHealthy 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	–	Device: µCorPatients 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.
Front Position Devices	–	–All devices placed in the front position
Side Position Devices	–	–All devices placed in the side position

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.

Key inclusion criteria (0 listed)

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
µCorSensor Monitor for arrhythmia and other bio-metric markers	Device	Arrhythmia Monitoring Group, Healthy Group

Primary outcome

Logistics of Study Device Setup and Monitoring
Time frame: 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
Time frame: 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.
Subject's Ability to Accurately Place Device
Time frame: 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
Time frame: Period 1 and Period 2
Count of subjects that had daily data transmission.
Ability to Provide Timely Arrythmia Monitoring
Time frame: 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.
Documentation of Clinically Actionable Events.
Time frame: 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.

6 secondary outcomes

Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Association of Device Recordings to Clinical Events
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Device Recording Stability
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
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Activity Front and Side Device Measurement Equivalency
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Sleep Angle Front and Side Device Measurement Equivalency
Time frame: Period 1: Start of device wear at Day 0 to Day 7

Results and safety

Results posted to the registry on 3 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Group	6	6
Arrhythmia Monitoring Group	45	45

Primary outcome: Logistics of Study Device Setup and Monitoring

Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90. Number. Unit: count of participants

Measure	Front Position Devices n = 51	Side Position Devices n = 51
Devices Assessed for Setup during Period 1	51	51
Devices Assessed for Monitoring during Period 1	51	51
Devices assessed for Monitoring during Period 2	22	23

Population analysed: All devices in both Healthy and Arrythmia Monitoring Group were assessed for setup at the beginning of Period 1. Monitoring assessment was assessed during both Period 1 and Period 2. There was a total of 51 side position devices and 51 front position devices.

Primary outcome: Device Wear Time and Compliance

Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90. Mean (Standard Deviation). Unit: Days

Measure	Front Position Devices n = 22	Side Position Devices n = 23
Value	68 (29)	54 (36)

Population analysed: Devices on subjects in the arrythmia group that were allocated for 90 day wear were used in the assessment.

Primary outcome: Subject's Ability to Accurately Place Device

Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90. Number. Unit: percentage of correct placements

Measure	Front Position Devices n = 51	Side Position Devices n = 51
Value	96	96

Population analysed: A position assessment and orientation placement was assessed for accuracy for all front and side devices.

Primary outcome: Device Data Transmission and Device Connectivity

Time frame: Period 1 and Period 2. Number. Unit: count of participants

Measure	Front Position Devices n = 51	Side Position Devices n = 51
Devices Worn during Phase 1	51	51
Devices Worn during Phase 2	22	23

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Group	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Arrhythmia Monitoring Group	0 of 45 (0%)	42 of 45 (93.3%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mike Osz study director

Zoll Medical Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Arrhythmia, run by Zoll Medical Corporation at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Logistics of Study Device Setup and Monitoring (time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04512703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.