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 个研究点目标入组 40 人开始时间: 2013年7月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

发起方

Infobionic