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Study withdrawn due to COVID endemic
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The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalConnect Platform | Device | The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological and irregular heart rhythm data in home and healthcare settings. This includes heart rate, electrocardiogram (ECG), heart rate variability (R-R interval), breathing rate, arrhythmia detection, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by authorized persons to notify healthcare professionals when physiological data falls outside selected parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit | Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject | Each patient will be monitored for up-to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of up to five-hundred (500) non-randomized subjects who have been recommended mobile cardiac telemetry by their care provider.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Sheehan, MD | VitalConnect Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Chevy Chase | Maryland | 20815 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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