Holter Versus Skiin Garments

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983484
• Other study ID #: MYANT/PACE - 073-1819-7
• Status: Completed
• Start date: October 16, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Myant Medical Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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).

Locations

Country	Name	City	State
Canada	Partners in Advanced Cardiac Evaluation (PACE) clinic	Newmarket	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Myant Medical Corp.	Partners in Advanced Cardiac Evaluation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Usable ECG	The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear	Throughout the entire data collection period, that is between 1 and 14 days
Primary	Difference in Heart Rate	The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear	Throughout the entire data collection period, that is between 1 and 14 days
Primary	Difference in RR intervals	The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear	Throughout the entire data collection period, that is between 1 and 14 days
Primary	Arrhythmic events	The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear	Throughout the entire data collection period, that is between 1 and 14 days
Secondary	Patient's perception	A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring).	At the end of the study, 1 to 14 days after initiation.