NCT05983484

Holter Versus Skiin Garments

Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Myant Medical Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions: * Can the textile sensors provide continuous monitoring and detect arrhythmias? * Do patients prefer to wear textile sensors instead of the Holter? Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	Skiin Underwear	All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-08-09
• Last updated: 2024-02-26

Locations

1 site across 1 country: Canada