Holter Versus Skiin Garments

NCT05983484 | Completed

• 1 other identifier: MYANT/PACE - 073-1819-7
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiac Arrhythmia

Keywords

ECG; Wearable; Holter

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Patient's perception

  At the end of the study, 1 to 14 days after initiation.

Interventions

Skiin Underwear DEVICE

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).

Also known as: PocketECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Myant Medical Corp.: lead
• Partners in Advanced Cardiac Evaluation: collaborator

Study Sites (1)

Partners in Advanced Cardiac Evaluation (PACE) clinic

Newmarket, Ontario, L3Y 2P6, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yaariv Khaykin, MD

  Partners in Advanced Cardiac Evaluation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: August 9, 2023
• Study Start: October 16, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CA (1)