Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility

NCT05821465 | Completed DMC

• 1 other identifier: V2.0
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Arrhythmias, Cardiac; Palpitation; Syncope; Light Headedness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Does the HeartWatch differ from the Event Recorder and Holter monitor in terms of adverse events?

  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.

  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

  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.

  Up to 48 hours.

Study Arms (2)

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

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

Interventions

HeartWatch DEVICE

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. Event Recorder; HeartWatch vs. Holter

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HelpWear Inc.: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Syncope; Dizziness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Sensation Disorders

Study Officials

• Derek Exner, MD

  HelpWear Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 20, 2023
• Study Start: July 1, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: July 22, 2024

Record last verified: 2023-04

Locations

CA (1)