Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Cardiac Arrhythmia Clinical Trial

— CATCH  

Official title:

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164808
• Other study ID #: CATCH V1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2023
• Source: HelpWear Inc.
• Contact: Karen Cowan
• Phone: 4035600225
• Email: kcowan[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients who are being referred to wear a holter monitor or a Sirona event recorder will e 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 and the HeartWatch vs Sirona recorder. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• At least 22 years of age at time of consent

• Clinically indicated for an ambulatory Event Recorder or Holter monitor test

• 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 Event Recorder

• Known allergy to any component of the Holter monitor

• Known allergy to any component of the HeartWatch

• Dextrocardia

• Implanted functional Pacemaker or Defibrillator

• Left bicep circumference < 22 cm

• Left bicep circumference < 45 cm

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HelpWear Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Evaluate and describe adverse events related to the use of the HeartWatch, Event Recorder and Holter devices.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours), and for the initial 48 hours of the Sirona vs the HeartWatch.
Other	User preference	Compare user preferences for the HeartWatch and Holter / Event Recorder devices.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours), and for the initial 48 hours of the Sirona vs the HeartWatch.
Other	10-minute averaged PR intervals	ss 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 patient wears the Holter monitor and the HeartWatch, 24-48 hours
Other	10-minute averaged QRS intervals	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 patient wears the Holter monitor and the HeartWatch, 24-48 hours
Other	10-minute averaged heart rate corrected QT (QTc) intervals	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 patient wears the Holter monitor and the HeartWatch, 24-48 hours
Primary	QRS signal detection	The proportion of QRS complexes detected by the Holter lead I reference signal which are also successfully detected by the HeartWatch will be computed separately for each patient;	For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours
Secondary	Event classification	All patient-tagged (symptomatic) events (all devices) and all non-normal clinically significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). ECG data will be adjudicated and classified using literature-based definitions. Non-interpretable ECG recordings will be classified as incorrect for an event if an interpretable categorization is obtained from one of the comparator devices.	For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours), and for the initial 48 hours of the Sirona vs the HeartWatch.