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The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm study to analyzable time for use in pediatric patients up to 14 days | Other | Zio monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zio monitor | Device | Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance Objective | The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time >80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time. | Up to 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Measures | The proportion of participants that experience clinically significant skin irritation during wear will be assessed via a skin irritation assessment performed by the healthcare provider. All adhesive-based wearable devices may lead to skin irritation. Minor itching and redness are expected. Skin reaction during wear should be reported as an adverse event. Adverse events will be reported and assessed for severity and relationship to the study device. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Berul, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States | ||
| St. Luke's Children's Hospital |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| D006330 | Heart Defects, Congenital |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| From enrollment to the end of the device wear period |
| Boise |
| Idaho |
| 83712 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| WashU Medicine | St Louis | Missouri | 63110 | United States |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |