Holter Versus Skiin Garments

Myant Medical

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Device: Skiin Underwear

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05983484

MYANT/PACE - 073-1819-7

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease.
• Age above 18
• Understand and speak English enough to consent and answer the study questionnaire.
• A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device)

Exclusion criteria

• Pregnancy
• Implanted defibrillator or pacemaker
• Absence of garment fitting the participant's body
• Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
• Severe frailty such that donning or doffing the garment may cause a danger of fall.
• Sensitive skin