Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.
At least 22 years of age at time of consent
Clinically indicated for a Holter monitor test
Able to wear the HeartWatch on the left bicep for the study duration
Able to follow the protocol
Known allergy to any component of the Holter monitor
Known allergy to any component of the HeartWatch
Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
Dextrocardia
Single group
HeartWatch
DeviceThe 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. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis.
QRS signal detection
Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal
ECG strip evaluation
Compare the overall agreement of the HeartWatch vs. Holter data in providing interpretable ECG strips data for all symptomatic (patient tagged) events and all cardiologist-verified non-normal rhythms identified by cardiology technologists (Holter).
ECG PR interval assessment
Assess the comparability of paired, 10-minute averaged PR intervals measured from the HeartWatch vs. the Holter lead I reference signal.
ECG QRS interval assessment
Assess the comparability of paired, 10-minute averaged QRS intervals measured from the HeartWatch vs. the Holter lead I reference signal.
ECG interval assessment
Assess the comparability of paired, 10-minute averaged heart rate corrected QT (QTc) intervals measured from the HeartWatch vs. the Holter lead I reference signal.
Adverse events
Evaluate and describe adverse events related to the use of the HeartWatch and Holter devices.
User preference
Compare user preferences for the HeartWatch and Holter devices
ECG strip categorization
Compare ECG strip categorizations of the HeartWatch vs. the Holter.
Future software validation
To use the ECG data signals collected to validate future software
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