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NCT Number: NCT06164808

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Cardiovascular Diseases Diagnostic/Monitoring Devices Related to Adverse Incidents Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location status: Recruiting

Location contact

Russell Quinn, MD

CONTACT

[email protected]

403-220-5500

About this study

Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No functional implantable pacemaker or defibrillator
  • Left bicep circumference >/= 22 cm and </= 45 cm
  • Provision of written-informed consent

Exclusion criteria

  • 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
  • Implanted functional Pacemaker or Defibrillator
  • Left bicep circumference < 22 cm
  • Left bicep circumference < 45 cm

Treatment and study plan

HeartWatch

Device

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. 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.

Primary outcomes

  1. QRS signal detection

    Time frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours

    Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal

Secondary outcomes

  1. ECG strip evaluation

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    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).

  2. ECG PR interval assessment

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    Assess the comparability of paired, 10-minute averaged PR intervals measured from the HeartWatch vs. the Holter lead I reference signal.

  3. ECG QRS interval assessment

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    Assess the comparability of paired, 10-minute averaged QRS intervals measured from the HeartWatch vs. the Holter lead I reference signal.

  4. ECG interval assessment

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    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.

Other outcomes

  1. Adverse events

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    Evaluate and describe adverse events related to the use of the HeartWatch and Holter devices.

  2. User preference

    Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

    Compare user preferences for the HeartWatch and Holter devices

  3. ECG strip categorization

    Time frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours.

    Compare ECG strip categorizations of the HeartWatch vs. the Holter.

  4. Future software validation

    Time frame: Data obtained during the recordings will be used for future software validation for 5 years.

    To use the ECG data signals collected to validate future software

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Cowan

CONTACT

[email protected]

4035600225

Owen Gillett

CONTACT

[email protected]

647-994-4077

Sponsors and collaborators

Lead sponsor

HelpWear Inc.

Industry

Registry information

Acronym: CATCH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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