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Trial registered on ANZCTR


Registration number
ACTRN12613000819729
Ethics application status
Not yet submitted
Date submitted
17/07/2013
Date registered
24/07/2013
Date last updated
24/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Assess How Well the MonitorMe Device Works in Detecting Known Heart Rhythm and Rate Irregularities in Patients With a Need for Cardiac Monitoring, and to Assess How User-friendly it is for the Patient.
Scientific title
A study to Assess the Usability and Functionality of the MoMe Trademark Continuous ECG Monitoring and Arrhythmia Detection System during a passive monitoring period under normal use conditions, to capture and identify arrhythmia in patients who have a demonstrated need for cardiac monitoring.
Secondary ID [1] 282844 0
Infobionic, MMNZ-001
Universal Trial Number (UTN)
U1111-1145-5695
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmias 289651 0
Condition category
Condition code
Cardiovascular 289967 289967 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will wear a device (MoMe) for 14-30 days at the physician's discretion, which is a Continuous ECG Monitoring and Arrhythmia Detection System attached to the surface of the skin on the chest via electrodes. The device will be removed when the patient needs to shower. The patient will remove the device and reattach it themselves. The time periods that the patient wears the device will be monitored and recorded.
Intervention code [1] 287532 0
Not applicable
Comparator / control treatment
There is no comparator or control in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290018 0
Successful use and device function per the Indications for Use during a passive monitoring period, where device use and functional success are defined as follows:
capture and identification of known arrhythmias during passive monitoring period
transmission of data capture via cloud application to remote service
retrieval of data captured via the iPad or web application interface
Timepoint [1] 290018 0
30 days
Secondary outcome [1] 303782 0
Subject Ease of Use assessed by questionnaire covering the topics:
Initial office set-up time/comprehension
In-home resets/reconnection of electrodes after activity(bathing/exercise), electrode connection
Timepoint [1] 303782 0
30 days
Secondary outcome [2] 303858 0
Manual notification to healthcare provider function.
Event notifications manually inputted by the participant will be detected by the device and the information will be transmitted to the data team and assessed
Timepoint [2] 303858 0
30 days
Secondary outcome [3] 303859 0
Smartphone interface use - will be assessed by measuring successful data transmission from smartphone to internet application
Timepoint [3] 303859 0
30 days
Secondary outcome [4] 303860 0
Healthcare provider Ease of Use - assessed by questionnaire completed by healthcare provider
Initial office set-up, subject explanation/training time
IPad/Web Application Interface usage
Timepoint [4] 303860 0
30 days

Eligibility
Key inclusion criteria
1.Male or female subject between the ages of 18-85 years old.
2.Subject has known, diagnosed arrhythmia of any type included in the Indications for Use for which no additional treatment or intervention is medically required during the monitoring period.
3.Subject agrees to comply with all study requirements including initial set-up clinical visit, monitoring period and follow-up visits.
4.Subject has completed signed written informed consent.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Female subject is pregnant or intends to become pregnant during the MoMe monitoring period.
2.Subject has an implanted ICD or pacemaker.
3.Subject has potentially life-threatening arrhythmias that require inpatient monitoring.
4.Subject the attending physician thinks should be hospitalized.
5.Subject that requires QT interval monitoring during the initiation of antiarrhythmic therapy; where in patient monitoring is required by the drug labeling.
6.Subject has undergone an interventional procedure or surgery within the past six (6) months.
7.Subject has any other medical condition that in the opinion of the investigator study participation would cause undue harm to the subject.
8.Subject is actively participating in any other investigational drug or device study.

Study design
Purpose
Screening
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5196 0
New Zealand
State/province [1] 5196 0

Funding & Sponsors
Funding source category [1] 287622 0
Commercial sector/Industry
Name [1] 287622 0
Infobionic
Country [1] 287622 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Infobionic
Address
M2D2,600 Suffolk Street
Lowell, MA 01854
USA
Country
United States of America
Secondary sponsor category [1] 286366 0
None
Name [1] 286366 0
Address [1] 286366 0
Country [1] 286366 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289593 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 289593 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington, 6011
New Zealand
Ethics committee country [1] 289593 0
New Zealand
Date submitted for ethics approval [1] 289593 0
26/07/2013
Approval date [1] 289593 0
Ethics approval number [1] 289593 0

Summary
Brief summary
This study will evaluate the usability and functionality of the MoMe continuous ECG monitoring and arrhythmia detection system. The device is intended for patients who have a demonstrated need for cardiac monitoring to detect arrhythmias (abnormal heart rhythms and rates) which could pose a danger to the patient’s health. The MoMe device records electrical signals from the heart through a series of electrodes attached to the chest, providing a range of information including the heart rhythm, heart rate, respiration rate, blood pressure and motion activity level. Standard of care ECG monitoring devices used only monitor heart activity for a short duration (24-48hrs) and because of this, transient arrhythmias can go undetected. The diagnosis by the doctor is also delayed as the device data has to be sent to a lab for review and analysis before he/she can receive it. The technology of this new MoMe device overcomes the issue of a missed or delayed diagnosis by facilitating heart monitoring for a longer period and by providing real time data to the physician for review at the current moment that the patient is wearing the device. The study will involve up to 40 patients at up to two New Zealand sites. Participants will be aged 18-85 and will have a previously diagnosed known arrhythmia for which no treatment or intervention is medically required during monitoring. Participants will have the device attached in the hospital by a trained technician and wear it for up to two weeks. The data will be continuously analysed for arrhythmias and transmitted to a cloud application where it can be viewed in real time. For the purposes of minimising bias in this research study, the investigator will be blinded to the patient’s data. The investigator will be informed by the Sponsor if any new arrhythmias are detected by the device. The patient will return to the hospital at the end of the monitoring period and have the device disconnected, at which point they will exit the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41482 0
Dr Ian Crozier
Address 41482 0
Christchurch Hospital
Cardiology Department
Private Bag 4710
Christchurch 8140
New Zealand
Country 41482 0
New Zealand
Phone 41482 0
+64,3,3640640
Fax 41482 0
+64,3,3786378
Email 41482 0
[email protected]
Contact person for public queries
Name 41483 0
Catherine Cruickshank
Address 41483 0
Level 2, Parkside West
Christchurch Hospital
Riccarton Avenue
Christchurch, 8013
New Zealand
Country 41483 0
New Zealand
Phone 41483 0
+64,3,3641096
Fax 41483 0
Email 41483 0
[email protected]
Contact person for scientific queries
Name 41484 0
Laura Minarsch
Address 41484 0
InfoBionic Inc.
M2D2 600 Suffolk St.
Lowell, MA. 01854
Country 41484 0
United States of America
Phone 41484 0
+1,949,2805700
Fax 41484 0
Email 41484 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.