Status:

COMPLETED

Holter Versus Skiin Garments

Lead Sponsor:

Myant Medical Corp.

Collaborating Sponsors:

Partners in Advanced Cardiac Evaluation

Conditions:

Cardiac Arrhythmia

Eligibility:

All Genders

18+ years

Brief 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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 16 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2024

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT05983484

Start Date

October 16 2023

End Date

February 1 2024

Last Update

February 26 2024

Active Locations (1)

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1

Partners in Advanced Cardiac Evaluation (PACE) clinic

Newmarket, Ontario, Canada, L3Y 2P6