Proof of Concept Study for 1 Lead Patch Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proof of Concept Study for 1 Lead Patch Technology

Conditions
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Telemetry

Intervention / Treatment
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* Device: 1-Lead Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-Lead Outpatient Telemetry<br>1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database. | Device: 1-Lead Patch<br>* The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Outcome Measure - 100% Successful ECG Acquisition | 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. | Between 7 and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch | 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. | Between 7 and 14 days |