Holter Versus Skiin Garments

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Skiin Underwear

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

• Study Contact: Name: Yaariv Khaykin, MD; Phone Number: 905 953 7917; Email: ykhaykin@pace-cardiology.com
• Study Contact Backup: Name: Jenny Gao-Kang; Email: JGaoKang@southlakeregional.org

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Partners in Advanced Cardiac Evaluation (PACE) clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adults with cardiovascular disease and/or risks justifying the need for performing an ECG Holter

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Myant Medical Corp.
• Collaborators: Partners in Advanced Cardiac Evaluation
• Investigators: Principal Investigator: Yaariv Khaykin, MD, Partners in Advanced Cardiac Evaluation

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ECG; Wearable; Holter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: MYANT/PACE - 073-1819-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No