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To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data.
This proof-of-concept study will enroll volunteers undergoing serial conventional 12-lead ECG rhythm strips who agree to wear a HeartWatch and use a Kardia mobile during those recordings.
The HeartWatch data will not be used for clinical decision-making. Rhythm strips from conventional 12-lead ECG recordings and the HeartWatch recordings will be obtained in volunteers in supine and standing positions and with the device placed in the recommended and in non-recommended positions (i.e., internally and externally rotated in keeping with the observed malposition identified in human factors testing environments (one inch or 2.5 cm; HelpWear, data on file).
Rhythm strips from serial 10-sec, 12-lead recordings will be obtained to allow for beat-by-beat comparisons of ECG intervals over the 20 to 30 seconds of noise free data. Specifically, the intervals from continuous v4 beats with paired continuous HeartWatch beats and the intervals from continuous lead I beats with paired continuous Kardia beats.
Since the HeartWatch is not intended to be used for evaluation of the ST segment or the QT interval, the comparison of the HeartWatch to standard lead v4 will exclude QT assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG signals collection | Device | A Health-Canada and FDA-approved 12-lead ECG system (GE Healthcare, MAC 5500 or equivalent) will be used to collect the 10-sec digital rhythm strips in the noted supine and standing positions. A total of twenty-four (24) recordings, four from each of position, will be collected from each consenting participant:
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard ECG and HeartWatch interval duration assessment in standard position | The three co-primary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a supine position with the HeartWatch in the standard location. | The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit. |
| Measure | Description | Time Frame |
|---|---|---|
| ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions. | Secondary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a:
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| Measure | Description | Time Frame |
|---|---|---|
| 12 Lead ECG and Kardia signal duration analysis from supine and standing positions | Exploratory endpoints for this study, for comparative purposes, are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (Kardia system vs. lead I of a standard 12-lead ECG) in supine and standing positions. | The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit. |
Inclusion Criteria:
Exclusion Criteria
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Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada | ||
| University of Calgary |
This information will be used to validate a company's Intellectual property
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| The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit. |
| Device related adverse events. | The safety endpoint for this study is the incidence of device-related adverse events. | Adverse events will be collected and assessed from all data collection visits immediately following every data collection visit. All adverse events will be followed until resolved or for up to 30 days after the event. |
| Calgary |
| Alberta |
| T2N 4N1 |
| Canada |