Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility (ALERT)

Ambulatory Leadless Electrocardiogram Recorder Trial (ALERT Feasibility)

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Syncope; Palpitation; Light Headedness
• Intervention / Treatment: Device: HeartWatch

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred for extended ambulatory ECG monitoring will be approached for participation. A total of 150 subjects will be enrolled into the two parallel studies, 50 subjects in the HeartWatch vs Event recorder and 100 subjects in HeartWatch vs Holter monitor.

Description

Inclusion Criteria:

• At least 22 years of age at time of consent
• Clinically indicated for an Event Recorder or Holter
• Able to follow the protocol
• Provision of written-informed consent
• No functional implantable pacemaker or defibrillator
• Left bicep circumference > 22 cm and < 45 cm

Exclusion Criteria:

• Known allergy to any component of the Event Recorder
• Known allergy to any component of the Holter monitor
• Known allergy to any component of the HeartWatch
• Dextrocardia
• Implanted functional Pacemaker of Defibrillator
• Left bicep circumference < 22 cm
• Left bicep circumference > 45 cm

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HeartWatch vs. Event Recorder; All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Event Recorder) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions.	Device: HeartWatch; The HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session.
HeartWatch vs. Holter; All patient-tagged (symptomatic) events recorded by the HeartWatch, and reference devices (Holter) and all non-normal clinically significant rhythm auto-triggered and recorded events will be adjudicated and classified using literature-based definitions.	Device: HeartWatch; The HeartWatch monitoring device will be worn on the upper left arm for the same duration or up to 48 hours that the standard event recorder or holter monitor is worn. The subject will be provided with a HelpWear smartphone that is paired to the monitor and only used by the participant to tag any events that they may have during the Heartwatch monitoring session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HeartWatch arrhythmia event characterization accuracy	An arrhythmia diagnosis will be applied to all patient-tagged (symptomatic) events (HeartWatch, Event Recorder, and Holter) and all abnormal significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). For the HeartWatch to be considered comparable to the Holter and Event Recorder, the accuracy of the HeartWatch to categorize the correct arrhythmia must be > 85% of the combined Holter and Event Recorder data.	Events will be assessed for the duration of time each participants wears the HeartWatch and holter/event recorder, up to 48 hours.
HeartWatch recording accuracy of QRS complexes	To be considered comparable to the Holter, the HeartWatch must detect > 90% of the QRS complexes recorded on the Holter lead I reference ECG signal	QRS complexes will be assessed for the duration of time each participants wears the HeartWatch and the holter monitor up to 48 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does the HeartWatch differ from the Event Recorder and Holter monitor in terms of adverse events?	The incidence of adverse events will be collected and compared between the HeartWatch vs the standard heart monitors	Events will be assessed up to 48 hours of the patient wearing the HeartWatch.
Evaluate if the HeartWatch will be similarly preferred to the Event Recorder and Holter monitor.	Subjects will complete a questionnaire that will allow them to indicate their user preference on reture of the device.	Up to 48 hours
The 10-minute averaged and paired PR/QRS intervals from the HeartWatch will be within 20 msec of the 10-minute averaged PR/QRS intervals from lead I of the Holter for at the same time points	The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear	Up to 48 hours.
the 10-minute averaged and paired QT intervals from the HeartWatch will be within 40 msec of the 10-minute averaged QT intervals from lead I of the Holter.	The 10-minute averaged PR, QRS, and QT intervals from the HeartWatch and Holter lead I will be analyzed using software created by HelpWear	Up to 48 hours.

Collaborators and Investigators

• Sponsor: HelpWear Inc.
• Investigators: Study Director: Derek Exner, MD, HelpWear Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Sensation Disorders; Unconsciousness; Consciousness Disorders; Arrhythmias, Cardiac; Dizziness; Syncope
• Other Study ID Numbers: V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No