Proof of Concept Study for 1 Lead Patch Technology

Not Applicable

Terminated

Brief Summary: This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.

Detailed Description: This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.

Recruitment & Eligibility

Inclusion Criteria

Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
Be recently prescribed a LifeWatch 3 Lead ACT monitor

Exclusion Criteria

under 21-years old
pregnant or who may become become pregnant during the investigation period
using internal or external defibrillators
who are using pacemakers or implantable loop recorders
showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
meeting any contraindications for a patch biosensor

Primary Outcome Measures

Name	Time	Method
Composite Outcome Measure - 100% Successful ECG Acquisition	Between 7 and 14 days	Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.

Secondary Outcome Measures

Name	Time	Method
Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch	Between 7 and 14 days	Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.