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Recruiting NCT06164808

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

No phase Interventional Cardiac Arrhythmia Diagnostic/Monitoring Devices Related to Adverse Incidents Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HeartWatch.
Who it may be relevant to
Registry conditions: Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF). Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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 whe

Primary outcome measures

  • QRS signal detection [Time frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours]
Secondary outcome measures (4)
  • ECG strip evaluation [Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG PR interval assessment [Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG QRS interval assessment [Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG interval assessment [Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • Foothills Medical Centre University of Calgary — Calgary

Identifiers

NCT: NCT06164808 · CATCH V3.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗