RecruitingNot ApplicableNCT06164808

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Sponsor

HelpWear Inc.

Enrollment

205 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiac Arrhythmia Diagnostic/Monitoring Devices Related to Adverse Incidents

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

Min Age: 22 Years

Inclusion Criteria7

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 Criteria7

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHeartWatch

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.