Telemetry
Conditions
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.
Interventions
DEVICE1-Lead Patch
The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
Sponsors
LifeWatch Services, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-Lead Outpatient Telemetry 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.
1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device did not turn on | 1 |
Baseline characteristics
| Characteristic | 1-Lead Outpatient Telemetry | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Region of Enrollment United States | — | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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.
Time frame: Between 7 and 14 days
Population: Data were not collected.
Secondary
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.
Time frame: Between 7 and 14 days
Population: Data were not collected.