ECG 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
Study 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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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