Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

NCT06164808 | Active Not Recruiting

• 1 other identifier: CATCH V1.0
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrhythmia; Diagnostic/Monitoring Devices Related to Adverse Incidents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ECG strip evaluation

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

• ECG PR interval assessment

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

• ECG QRS interval assessment

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

• ECG interval assessment

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

Other Outcomes (4)

• Adverse events

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

• User preference

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

• ECG strip categorization

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

Study Arms (1)

Active device engagement

OTHER

All subjects will wear either the Holter monitor and the HeartWatch.

Device: HeartWatch

Interventions

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.

Active device engagement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HelpWear Inc.: lead

Study Sites (1)

Foothills Medical Centre University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell Quinn, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will wear the Holter monitor and the HeartWatch.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: February 20, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)