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Study was halted to make device updates
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Lead Outpatient Telemetry | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-Lead Patch | Device | The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD FACC FHRS | Mt. Sinai Medical Center | Principal Investigator |
| Marie Noelle-Langan, MD | Mt. Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The single enrolled subject did not complete study procedure. Therefore no analysis was completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data were not collected. | Posted | Between 7 and 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Hanneman | LifeWatch Services, Inc. | 1 847 720 2231 | Phanneman@gobio.com |
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| Between 7 and 14 days |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed. | Count of Participants | Participants |
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| Region of Enrollment | The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed. | Number | participants |
|
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| 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. | Data were not collected. | Posted | Between 7 and 14 days |
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