Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05821465 |
Other study ID # |
V2.0 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 14, 2023 |
Est. completion date |
April 30, 2024 |
Study information
Verified date |
April 2023 |
Source |
HelpWear Inc. |
Contact |
Nabil Uddin |
Phone |
647-863-2420 |
Email |
nabil.uddin[@]helpwear.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this study is to compare the heart signals that are received by a new heart
monitoring device called the HeartWatch to heart signals that are recorded by existing
monitors used in cardiology clinics today. The main question[s] it aims to answer are:
1. Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia
events that are equivalent to the existing Event Recorder and Holter devices?
2. Does the HeartWatch recording allow for detection of QRS complexes that are equivalent
to the predicate Holter lead I reference signal? Participants who have been recommended
to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch
armband monitor at the same time as the standard heart monitor. They will be asked to
flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone.
When their monitoring session for the standard heart monitor is complete, then the
monitoring session for the HeartWatch armband is also complete.
Description:
Two general types of consumer products are used to monitor patients with or at risk of heart
rhythm disorders. Most estimate heart rhythm using blood flow (photoplethysmography) alone or
in combination with activity sensors (accelerometer). These methods are not reliable in
detecting heart rhythm abnormalities. Other methods record an ECG when the patient has
symptoms. These devices are useful, but require the wearer to recognize their symptoms,
attach the device and rest quietly to obtain an ECG recording of reasonable quality. The user
then needs to send that information to a healthcare provider to verify. Hence, these
consumer-based technologies are far from ideal. However, the diagnostic accuracy of
single-lead ECG via wearable medical devices is excellent and, likely superior to a family
physician's interpretation of a 12-lead ECG.3 High-quality ECG data from wearable devices
that can unequivocally document AF can expedite its detection, allowing prompt diagnosis and
appropriate prescription of antithrombotic and other therapies.
The HeartWatch arm band is designed to provide non-invasive, continuous single lead ECG data,
irrespective of activity, the environment, and other factors. It continuously records ECG
data for subsequent, offline analysis. The HeartWatch allows the user to note (flag) any
symptoms they experience (e.g., palpitations, light-headedness, fainting, etc…) to allow for
symptom-rhythm correlation and subsequent review by a physician. The HeartWatch displays all
the elements of an ECG signal (i.e., PQRST) to facilitate diagnoses by physicians and is
comparable to lead I of a traditional ECG system.
The HeartWatch is indicated for the extended diagnostic evaluation of patients with
symptomatic and transient symptoms such as light-headedness, syncope and palpitations, as
well as patients at risk for arrhythmias, but without significant symptoms.
The primary purpose of the study is to compare the interpretability of all tagged and all
non-normal clinically significant arrhythmia events and the detection of QRS complexes by the
HeartWatch, an upper armbased, ambulatory, single lead ECG collection tool, vs. conventional
Event Recorder or Holter monitor reference device.