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Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless telemetry vest in cardiac rehabilitation.
Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating the NimbleHeart chest harness system.
20 subjects will be consented to participate at an early cardiac rehabilitation exercise session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with existing telemetry system during exercise sessions, and thus not replace existing telemetry monitoring. Both staff and subjects will be queried for their (user) experiences during and after each session. Experiences will be documented on surveys after each session. De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions. Study participation will end after the 2nd session.
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system. | How "easy" or "difficult" it is to apply the harness system as compared to existing telemetry system. Scores range from 1 to 5 scale where 1 = More difficult and 5 = Much easier | 3 to 4 months |
| Reported occurrences of subject discomfort | Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort | 3 to 4 months |
| Quality of ECG tracings during exercise | Degree of ECG quality to determine heart rate and detect arrhythmia during subject exercise Scores range from 1 to 3 scale where 1 = Poor and 3 = Good | 3 to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac Rehabilitation phase II population
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 7, 2023 | |
| Reset | Apr 23, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 7, 2023 | Apr 23, 2024 |
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