Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch (CATCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrhythmia; Diagnostic/Monitoring Devices Related to Adverse Incidents
• Intervention / Treatment: Device: HeartWatch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Cowan; Phone Number: 4035600225; Email: kcowan@ucalgary.ca
• Study Contact Backup: Name: Owen Gillett; Phone Number: 647-994-4077; Email: owen.gillett@helpwear.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Recruiting
      • Foothills Medical Centre University of Calgary
      • Contact: Russell Quinn, MD; Phone Number: 403-220-5500; Email: frquinn@ucalgary.ca

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Active device engagement; All subjects will wear either the Holter monitor and the HeartWatch.

Device: HeartWatch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QRS signal detection	Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal	For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
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.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
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.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
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.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Evaluate and describe adverse events related to the use of the HeartWatch and Holter devices.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
User preference	Compare user preferences for the HeartWatch and Holter devices	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG strip categorization	Compare ECG strip categorizations of the HeartWatch vs. the Holter.	For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours.
Future software validation	To use the ECG data signals collected to validate future software	Data obtained during the recordings will be used for future software validation for 5 years.

Collaborators and Investigators

• Sponsor: HelpWear Inc.
• Investigators: Principal Investigator: Russell Quinn, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Disease; Arrhythmias, Cardiac
• Other Study ID Numbers: CATCH V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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