Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch (CATCH)

HelpWear

Status: Active, not recruiting

Conditions: Diagnostic/Monitoring Devices Related to Adverse Incidents; Cardiac Arrhythmia

Treatments: Device: HeartWatch

Study type: Interventional

Funder types: Industry

Identifiers

NCT06164808

CATCH V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Active device engagement

Other group

Description:

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

Treatment:

Device: HeartWatch

Sponsor of this trial

Lead Sponsor

HelpWear