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.
- Conditions
- ArrhythmiasCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12613000819729
- Lead Sponsor
- Infobionic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>capture and identification of known arrhythmias during passive monitoring period<br>transmission of data capture via cloud application to remote service<br>retrieval of data captured via the iPad or web application interface<br>[30 days]
- Secondary Outcome Measures
Name Time Method Subject Ease of Use assessed by questionnaire covering the topics: <br>Initial office set-up time/comprehension <br>In-home resets/reconnection of electrodes after activity(bathing/exercise), electrode connection<br>[30 days];Manual notification to healthcare provider function. <br>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[30 days];Smartphone interface use - will be assessed by measuring successful data transmission from smartphone to internet application[30 days];Healthcare provider Ease of Use - assessed by questionnaire completed by healthcare provider<br>Initial office set-up, subject explanation/training time<br>IPad/Web Application Interface usage<br>[30 days]