ECG Monitoring
Conditions
Keywords
Heart Signals, ECG
Brief summary
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.
Detailed description
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.
Interventions
DEVICEECG signals collection
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: * Supine with HeartWatch in the recommended position * Standing with HeartWatch in the recommended position * Supine with HeartWatch in a one inch (2.5 cm) externally rotated position * Supine with HeartWatch in a one inch (2.5 cm) internally rotated position * Supine while collecting a 30-sec Kardia recording * Standing while collecting a 30-sec Kardia recording
Sponsors
HelpWear Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 22 years of age at time of the conventional ECG recording * Willing to participate in the study * Able to follow the protocol
Exclusion criteria
* Known allergy to the electrodes used for a conventional ECG * Known allergy to any component of the HeartWatch * Known allergy to any component of the Kardia system * Inability to wear the HeartWatch on the left arm due to pre-existing medical condition (e.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot or recurrent blood clots in left arm, chronic neuropathic pain in left arm, …) * Dextrocardia * Implanted functional Pacemaker of Defibrillator * Left upper arm circumference \< 22 cm or \> 45 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard ECG and HeartWatch interval duration assessment in standard position | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional 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. | 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: 1. standing position with the HeartWatch in the standard location; 2. supine position with the HeartWatch in a one inch (2.5 cm) externally rotated; 3. supine position with the HeartWatch in a one inch (2.5 cm) internally rotated. |
Countries
Canada
Outcome results
None listed