Holter Versus Skiin Garments

Last updated: February 23, 2024
Sponsor: Myant Medical Corp.
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Circulation Disorders

Atrial Flutter

Treatment

Skiin Underwear

Clinical Study ID

NCT05983484
MYANT/PACE - 073-1819-7
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed orsuspected 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 orAndroid), compatible with the Skiin app (application used to monitor the patient usingthe wearable device)

Exclusion

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 withthe Skiin electrodes
  • Severe frailty such that donning or doffing the garment may cause a danger of fall.
  • Sensitive skin

Study Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: Skiin Underwear
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
February 01, 2024

Connect with a study center

  • Partners in Advanced Cardiac Evaluation (PACE) clinic

    Newmarket, Ontario L3Y 2P6
    Canada

    Site Not Available

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