Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Last updated: July 19, 2024
Sponsor: HelpWear Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Fast Heart Rate (Tachycardia)

Circulation Disorders

Atrial Fibrillation

Treatment

HeartWatch

Clinical Study ID

NCT06164808
CATCH V1.0
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 topre-existing medical condition (3.g., functional AV fistula in left arm, priorcarcinoma with lymph node dissection or lymphedema, known blood clot of recurrentblood 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 Design

Total Participants: 205
Treatment Group(s): 1
Primary Treatment: HeartWatch
Phase:
Study Start date:
February 20, 2024
Estimated Completion Date:
October 01, 2024

Study 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.

Connect with a study center

  • Foothills Medical Centre University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

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