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.

Infobionic0 sites40 target enrollmentJuly 24, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 24, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Observational

Sex

All

Sponsor

Infobionic

•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.