Clinical Data Validation of Novel Wireless Cortrium C3 Monitor for Continuous Electrocardiogram Measurements

January 22, 2020 updated by: Cortrium
The purpose of this study is to validate the quality of the ECG-signal acquired with the Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring methods used in clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Development of new cost effective mobile devices and wireless technology has great potential in supervision of critically ill patients in wards as well as ambulant. Through continuous wireless monitoring in both the hospital and the patients home, detection of heart arrhythmias such as atrial fibrillation (AF) will be possible.

AF is the cause of a sizeable amount of strokes (15% of all, and more than 35% of the population over 80 years of age), which can be prevented through anticoagulation treatment if provided in time. Thus, many patients are referred to cardiologic ambulatory to be examined for AF, and are subjected to heart monitoring with a so-called Holter or event monitor. This entails the patient be equipped with several electrodes on the chest, to which leads are attached and connected to a sizable and bulky box. The patient carries this box around hanging from the shoulder, belt or something similar for one or several days. It is then required of the patient to come back and deliver the device, after which the data must be read and analysed, in order to work out a further plan for the patient. During admission, a similar system can be attached for continuous heart monitoring.

Cortrium (http://cortrium.com) has developed a wireless technology, where a small C3 monitor is attached to the chest with standard electrodes and the leads are built into the actual monitor. The quality of the signal has been tested on healthy adults, but is yet to be tested on patients suffering from arrhythmias

The purpose of this study is to validate the quality of the ECG-signal acquired with the Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring methods used in clinical practice.

The measurements are performed on patients under investigation for AF at cardiology ambulatory Y at Frederiksberg-Bispebjerg Hospital and Aleris-Hamlet Hospital, Copenhagen. The patients are outfitted with a C3 monitor simultaneous with the use of the conventional ambulatory apparatus. This is a "Holter monitor" (Rozinn station RZ152+12 and RZ153+ from ScottCare Holter for Windows 2010 (CE0120) and "EventCare SA version" (CE0120), both bought via SEMCA Ap, Skævinge, Denmark.

Recordings with the usual apparatus are analysed in the usual fashion in the cardiology ambulatory. A copy of the recordings is registered anonymously and paired with the simultaneous recordings from the C3. The diagnosis is made by two observers, blinded to both patient identity and data source. Thus, data will not be personally identifiable. Validation is performed in collaboration with the department of cardiology.

Statistics:

With simultaneous supervision of 77 patients with increased incidence of AF it will be possible to determine whether the C3 is capable of detecting AF in at least 95% of the cases which Holter detects. Since the incidence of AF Is lower in the total patient group referred to Holter monitoring, we plan to include 150 patients to acquire the usable number of examinations.

Economic Conditions Helen Dominguez is the unfunded, and the responsible consultant of the study. Opeon Aps delivers C3 monitors for this clinical trial as well as brochure guides for patients and health care personnel. There are no economic benefits connected with the present clinical trial.

Publication of Results:

Opeon ApS (owner of Cortrium) is responsible for processing the material for publication of results in an international peer-reviewed journal as well as in the Danish popular scientific press related to new Medical equipment. Positive, negative and inconclusive results will be published.

Recruitment of Participants:

Patients who have planned ambulatory arrhythmia recording for diagnosis of intermittent AF will be asked by telephone to consider participating in the study.

After reading the participant information flyer, the subjects are invited to in-depth verbal information in the ambulatory. If the subjects accept to participate and provide a signed informed consent, they outfitted with a C3 monitor along with the standard Holter apparatus.

The study only includes subjects scheduled for Holter monitoring referred for atrial fibrillation examination, quantification of paroxysms, or heart rate during paroxysms.

Ethical Considerations:

Ethical Considerations: If the patient agrees to take part in the study, the main disadvantages are that it entails attachment of another three electrodes for the C3 monitor, increasing the risk of skin irritation, and receiving additional instructions for two devices. Since ECG recordings are non-invasive, and the C3 recordings do not result in further ambulatory visits than otherwise planned, we estimated that the strain on the patients is very limited.

The use of C3 for estimation of AF in future patients will decrease the trouble of loose leads. For this reason, using the C3 will also simplify the work of the healthcare personnel during the attachment procedure. Overall it may lead to an increase in quality as well as increase the capacity for examining cardiac arrhythmia in the cardiology ambulatory.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Department of Cardiology, Bispebjerg-Frederiksberg Hospitals
      • Soborg, Denmark, 2860
        • Aleris-Hamlet Private Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of atrial fibrillation
  • Investigation of atrial fibrillation

Exclusion Criteria:

  • Language difficulties
  • Impaired cognitive function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AF assessed from Cortrium C3 data
Atrial fibrillation assessed from Cortrium C3 device data
Device: Cortrium C3 device
Data is read from Cortrium C3 monitor
Device: Holter device
Date is read from Holter device
Experimental: AF assessed from Holter data
Atrial fibrillation assessed from Holter data
Device: Cortrium C3 device
Data is read from Cortrium C3 monitor
Device: Holter device
Date is read from Holter device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: Through study completion, an average of 3 months
Expert readings of long-term ECG reports to assess number of AF paroxysms.
Through study completion, an average of 3 months
Heart rate (BPM) during atrial fibrillation
Time Frame: Through study completion, an average of 3 months
Expert readings of long-term ECG reports to assess heart rate in BPM.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cortrium

Collaborators

Aleris-Hamlet Hospitaler København
University Hospital Bispebjerg and Frederiksberg

Investigators

  • Principal Investigator: Helena Helena, MD, PhD, Bispebjerg-Frederiksberg Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15006113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Study Protocol
    Information comments: In Danish language

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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